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Associate Sample Coordinator
Thermo Fisher Scientific, Middleton
Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.Discover Impactful Work:Performs duties and training to acquire the skills required for sample and standard handling in support of the laboratory. Provides support to Sample Coordinator and performs administrative tasks in the Sample Management department. Follows SOPs, applicable client procedures, and fulfills laboratory requests with modest direct supervision.A day in the Life:Performs a variety of simple inventory tracking procedures (receipt, check-in, login, labeling, inventory, transport, check-out, etc.) and administrative tasks in support of laboratory operations.Communicates status of tasks to supervisor and/or appropriate laboratory staff.Trains on SOPs, regulatory guidelines, and storage requirements.Supports response to environmental unit alarms and may participate in on-call responsibilities.Performs daily work assignments accurately, timely and in a safe manner.Keys to Success:EducationHigh / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationTechnical positions may require a certificateExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year) or equivalent combination of education, training, & experience.Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.Knowledge, Skills, AbilitiesFamiliarity with Microsoft Office including Word and ExcelTime management skillsAbility to maintain detailed tracking and documentation clearly and accurately according to SOPWritten and oral communication skillsAbility to work in a collaborative team environmentWorking environmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects of 15 to 40 poundsAble to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.Exposure to fluctuating and/or extreme temperatures on rare occasionsOur Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Lab Support Tech (M-F 2nd Shift)
Thermo Fisher Scientific, Middleton
Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.Discover Impactful Work:Works with various teams (metrology, sample entry, stability, etc.) and assists in maintenance of laboratory systems. Supports daily lab operations under the direction of a senior staff member. Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements. Follow Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs).A day in the Life:Understands and conforms to all standard operating procedures, methods, and protocols applicable to assigned tasks.Maintains compliant laboratory documentation. Ensures all laboratory equipment and work areas are clean, sterile, and in proper working order.Routinely operates laboratory equipment.Communicates task status to laboratory manager or designee.Performs daily work assignments accurately and in a timely manner.Keys to Success:EducationHigh / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year) or equivalent combination of education, training, & experience.Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.Knowledge, Skills, AbilitiesAbility to follow laboratory safety proceduresEffective communication skillsGood cooperative and collaborative skillsAttention to detailAbility to adhere to laboratory policies and standard operating proceduresData recording skillsAbility to work in a collaborative team environmentWorking EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 pounds.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Validation Analyst
Thermo Fisher Scientific, Middleton
Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.Provides basic business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitates the validation process and implementation of system upgrades, including guiding, testing, supporting the introduction and ongoing support of software systems.A day in the Life:Participates as a validation representative at project team meetings and completes assigned action items. Provides direction for future releases to software systems; reviews and approves/rejects change requests. Communicates proactively with all project team members and provides regular feedback to management concerning timeline/budget or resource constraints.Provides validation support for new releases and modifications to applications throughout the software development life cycle. Prepares validation plans, test cases and validation summary reports, and executes test cases.Reviews and approves all change controls associated with validated systems per SOP. Reviews PQ and change control documentation with leadership per SOP.Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer.Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably, proving the software functions correctly. Creates, updates, and manages sufficient data within the testing environment to accurately test software functionality. Works with leadership to address any PQ related issues arising from client or internal audits.Manages assignments to meet deadlines and produce high quality deliverables. Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs.Participates in the identification of user requirements and system design and assists in the preparation and review of system documentation such as requirements and design specifications for software systems and/or instrumentation.Keys to Success:EducationBachelor's degree or equivalent and relevant formal academic / vocational qualificationExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills, AbilitiesClient-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach othersStrong attention to details and problem-solving skillsDemonstrated competency with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to learn new computer software with minimum of instructionPositive attitude, enthusiasm toward work, and the ability to work well with othersEffective organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlinesSolid understanding of clinical trials operational processes and terminology and solid understanding of the software development life cycle (SDLC)Strong troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and explain how errors are producedAbility to attain, maintain, and apply a working knowledge of GCPs, applicable SOPs/WPDs, and process mapsAbility to review and critique SDLC documentation including requirements, functional design, system design, and test plans. Ability to assess the cause of test failuresDemonstrated ability to coordinate project activities and work and communicate effectively on a multi-disciplinary teamPhysical Requirements / Work EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary for typical working hours.Ability to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.May require travel. (Recruiter will provide more details.)Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Associate Group Leader (Sunday - Thursday) - Cell Lab
Thermo Fisher Scientific, Middleton
Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.Discover Impactful Work:Provides management and direction to laboratory staff and resources for project activities and needs, supervise daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs. Ensures responsiveness to the customer and overall, client satisfaction. Plans and monitors the progress and quality of projects by applying the financial and quality management tools available at PPD.A day in the Life:Prepares, reviews and approves study protocols, project status reports, final study reports and other project-related technical documents.Designs experimental study and participates in technical troubleshooting.Reviews data for technical quality and compliance to protocols, methods and SOPs. Reviews and approves laboratory investigations, deviations, and QA facility and data audits. Leads client and FDA audits.Allocates, schedules and manages laboratory resources for group's project activities and updates project status. Reviews timesheet reports for billing accuracy.Responds to client's questions and needs; leads client technical meetings.Assists in preparation of proposals by provided project definition.Identifies new opportunities within client base and ability to work with business development to pursue opportunities.Coordinates and prioritizes project activities with internal functional groups (physical testing, analytical development, microbiology, etc.) and support functions (QA, sample management, etc.).Assists management in their responsibilities.Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.Qualifications - ExternalKeys to Success:EducationBachelor's degree or equivalent and relevant formal academic / vocational qualificationExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years) or equivalent and relevant combination of education, training, & experience.1+ year of leadership responsibilityIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills, AbilitiesShown leadership skillsAbility to cultivate a collaborative work environment with a teamEffective negotiating skillsProven knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPsAbility to troubleshoot multiple systems/methodologiesAbility to independently optimize analytical methodsUnderstanding of basic financial terms and definitions as it applies to the businessUnderstanding of proposal and project scope as it relates to pricing, resource management and the impact on businessProject and time management skillsEffective written and oral communication skills as well as presentation skillsAbility to train and mentor junior staffWork EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 pounds.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Lead Facilities Coordinator
Thermo Fisher Scientific, Middleton
Job DescriptionLead Facilities Coordinator - Middleton, Wisconsin*This position will have rotating on-call responsibilities*At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Location/Division Specific InformationOur PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.Discover Impactful Work:As a Lead Facilities Coordinator you will provide lead site support through the coordination and performance of diverse activities related to facility services, building maintenance, engineering projects, and equipment maintenanceA day in the Life:Coordinates and performs multiple and at times complex facilities support services to include project execution, triaging work orders such as building maintenance and repairs, equipment setup and maintenance, and/or the coordination of transportation services.Coordinates assigned activities with outside contractors and vendors, as needed.Makes recommendations for improving service delivery and procedures.Responds to facility-related emergencies, as assigned.May cross-train or mentor department staff.Keys to Success:EducationHigh / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationExperienceTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 years).Knowledge, Skills, AbilitiesDemonstrated ability to handle multiple projects and balance prioritiesPositive attitude and the ability to interact effectively with othersStrong computer skills, including Microsoft OfficeStrong problem-solving skillsAbility to communicate with a wide variety of specialized outsourced suppliers and vendorsMay require advanced knowledge of building systems including, but not limited to, HVAC, plumbing, electrical, and controlsMay require a good understanding of security systemsPhysical Requirements / Work Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to move effectively throughout facility, including lifting and moving objects up to 35-50 pounds.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Senior Group Leader - Cell Bioassay
Thermo Fisher Scientific, Middleton
Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.As a Senior Group Leader, provide line-level management coordination of resources and work schedules for laboratory activities. Summarized Purpose: Provides oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc. Manages the work activities of group and associate group leaders, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting method and product-related issues. Ensures the compliance of work performed within the laboratory as well as working with manager to meet the financial goals of the organization.Essential Functions: Reviews and approves study protocols, project status reports, final study reports and other project related technical documents. Designs experimental studies and participates in technical troubleshooting.Allocates, schedules and manages laboratory resources for group's project activities and updates project status and revenue projections. Reviews timesheet reports for billing accuracy.Reviews data for technical quality and compliance to protocols, methods and SOPs. Approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits.Responds to clients questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues.Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with client on timelines and budget.Identifies business opportunities at conferences, workshops, within the community, through client interaction, etc. Participates in technical sales and marketing; prepares technical marketing materials. Works with business development as technical representative for client visits/discussions.Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.Accountable for group's knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements.Participates in bi-annual SOP review & change. Ownership of changes needed to comply with SOPs.Regularly communicates to staff quality related issues and items for staff development and implements quality improvements.Qualifications - ExternalBachelor's degree or equivalent and relevant formal academic / vocational qualificationEducation and Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience. 2+ year of leadership responsibility In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Demonstrated proficiency on technical operating systems Experience in biosafety, biologics safety testing, mycoplasma and viral safety, viral clearance, and adventitious agentBackground in transmission electron microscopy (TEM) including operation and execution of TEM protocols Previous experience with testing of cell banks and production cell cultures on the presence of retroviral particles is a plusProven leadership skills Ability to train and mentor junior staff Demonstrated ability to be project solution driven Good written and oral communication skills as well as presentation skills Can independently perform root cause analysis for method investigations Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.) Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs Ability to independently optimize analytical methods Project and time management skills Work EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 pounds.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
Accounting Manager / Accountant for MEMPHIS Manufacturing
Austin Allen Company, LLC 1233, Middleton, TN, US
Accounting Manager / Accountant MEMPHIS ManufacturingSalary $90,000 - $100,000 + Benefits in the MEMPHIS areaA leading manufacturing company needs a skilled Accounting Manager for their plant. You’ll report to the Site Controller and work extensively with the management team preparing financial statements & their analysis. You’ll be a significant team member supporting the reconciliation of the general ledger, balance sheet accounts, and in the month end close process.You’ll manage the accounts payable process and work with cross functional teams including Purchasing / Supply Chain, Distribution, Sales & Customer Service.You’ll need experience with corporate accounting processes, multiple plant integration, and the standard costing process. You’ll need to have the drive to be accurate, the ability to meet deadlines, be well-organized, and able to communicate well with an extensive group.Minimum requirements for this Accounting Manager position:• Bachelor’s degree in accounting, Finance, Econ, or BBA• At least 5 years’ of accounting experience that includes cost accounting, A/P, & A/R in a manufacturing environment• Must be proficient in Excel.TO APPLY: Email your resume OR angieATaustinallenDOTcom in MS Word or PDF (please remove the capital letters and replace with proper symbols). * All Interview, relocation, & fee expenses paid by hiring companies. Hiring companies offer excellent compensation packages, benefits, and, where available, generous relocation assistance or packages.Areas of Specialization...* Engineering * Six Sigma Black Belts * Accounting * Distribution * Human Resources* Materials / Purchasing * Quality Engineers & Managers * Manufacturing Management
Technical Project Manager - Container Closure Integrity
Thermo Fisher Scientific, Middleton
Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.Discover Impactful Work:Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.A day in the Life:Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and /or biological matrices for stability and analytical testing.Works with multiple functional groups to meet business needs.Plans and organizes work with periodic supervision.Sets up and maintains analytical instrumentation.Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.Ensures QA findings are addressed appropriately.Aids and training to other team members.Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.Communicates project status to project leader.Performs work assignments accurately, and in a timely and safe manner.Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.Qualifications - ExternalKeys to Success:EducationBachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.Knowledge, Skills, AbilitiesDemonstrated knowledge of multiple applicable techniques such as: HPLC, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOCProficient in Microsoft Excel and WordProven ability to interpret data by performing trend analysisProven ability in technical writing skillsAbility to independently optimize analytical methodsProven problem solving and troubleshooting abilitiesGood written and oral communication skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamWork EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 pounds.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Associate Research Scientist - Cell and Gene Therapy - HPLC/CGE
Thermo Fisher Scientific, Middleton
Job DescriptionAssociate Research Scientist - Routine TeamCell and Gene Therapy DepartmentMiddleton, Wisconsin, United States of AmericaJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.Discover Impactful Work:Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.A Day in the Life:Support late phase or commercial client on release and stability projects.Protocol and method generation, technical support to the team, client communications, nonconformance writing and leading OOS investigations.Works with multiple functional groups to meet business needs.Plans and organizes work with periodic supervision.Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.Qualifications - ExternalKeys to Success:EducationMS degree with 4+ years of experience; BS degree with 6+ years of experience.ExperienceLaboratory experience involving CE, HPLC, ELISA and compendia.Experience with Release and Stability programs.Prior client interfacing experience needed.Experience delivering project completion to timeline.Teamwork: data sharing, problem-solving, and collaborating.Knowledge, Skills, AbilitiesKnowledgeable in several of the following areas: HPLC, UPLC, iCE, CGE, MS, ELISA, SDS-PAGE, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOCProficient in Microsoft Excel and WordProven ability to interpret data by performing trend analysisProven ability in technical writing skillsAbility to independently optimize analytical methodsProven problem solving and troubleshooting abilitiesGood written and oral communication skillsTime management and project management skillsAbility to work in a collaborative work environment with a teamSkilled at written and verbal communication, documenting and sharing experimental methods, data, outcomes, and conclusions to diverse audiences.Ability to identify issues and adapt experiments on-the-fly, a skill facilitated by strong attention to detail and a willingness to ask for help.Skilled at prioritization and navigating ambiguity with a positive demeanor.Work EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 pounds.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
PRODUCE/ASST DEPT LEADER
The Kroger Co., Middleton
Create an outstanding customer experience through exceptional service. Establish and maintain a safe, clean environment that encourages our customers to return. Achieve sales and profit goals established for the department and control all established quality assurance standards. Monitor all functions, duties and activities related to the Produce department. Demonstrate the company s core values of respect, honesty, integrity, diversity, inclusion and safety. Minimum - Excellent oral/written communication skills- Current food handlers permit once employed- Ability to handle stressful situations- Knowledge of basic math (counting, addition, subtraction) Desired - High School Diploma or GED - Any produce/retail experience- Any management experience- Second language (speaking, reading and/or writing)- Promote trust and respect among associates, with a positive attitude- Communicate company, department, and job specific information to associates- Establish department performance goals and empower associates to meet or exceed targets through teamwork- Develop adequate scheduling to manage customer volume- Train and develop associates on their job performance and participate in the performance appraisal process- Create an environment that enables customers to feel welcome, important and appreciated by answering questions regarding products sold within the department and throughout the store; respond to questions, make suggestions, and locate products- Inform customers of produce specials and offer product samples to help customers discover new items- Review/inspect products for quality and freshness and take appropriate action- Develop and implement a department business plan to achieve desired results- Create and execute sales promotions in partnership with store management- Inform and educate department associates about current, upcoming and special in-store promotions, especially promotions that affect the department- Prepare and submit seasonal critiques for the sales and merchandising supervisor- Implement the period promotional plan for the department- Assist management in preparing the store/department budget, expense control, profit and loss reviews, and take appropriate action on all financial reports- Schedule daily, weekly and monthly price changes by updating shelf tags and promotional signs- Plan and organize the inventory process, maintain an awareness of inventory/stocking conditions, note any discrepancies, train department associates on inventory/stocking and Computer Assisted Ordering (CAO)- Ensure proper temperatures in cases and coolers are maintained and temperature logs are maintained- Reinforce safety programs by complying with safety procedures, identifying unsafe conditions, practicing preventive maintenance by properly inspecting equipment, notifying store management of any items in need of repair and of customer or employee accidents- Report all safety risk, or issues, and illegal activity, including robbery, theft or fraud- Adhere to all local, state and federal laws, and company guidelines- Must be able to perform the essential job functions of this position with or without reasonable accommodation