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QA Specialist Salary in USA

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QA Specialist - I*
American Cybersystems, Inc., Frederick
Innova Solutions is immediately hiring a Quality Assurance Specialist I Position type: Full-time Contract Duration: 12 months and possibility for extension Location: Frederick, MD ***Shift is Sun-Wed 7am- 5:30 pm*** *** This position will be 100% On-Site***As aQuality Assurance Specialist I, you will: Provide QA support on the floor for production • Ensure process control measures are in place and followed in product manufacturing • Receipt and disposition of incoming apheresis material. • Oversee and authorize shipment of final product • Verify and ensure timely issuance of production documents and labels • Review batch-related documentation and ensure resolution of issues to release and ship product. • Gather and report metrics to measure performance • Identify continuous improvement actions • Ensure timely resolution and escalation of issues • Ensure all product-related Deviations are initiated, investigated and resolved. • Ensure that associated CAPAs are initiated and resolved, as needed. • Perform lot closure activities. • Ensure approval and timely delivery of final product. • Ensure products are manufactured in compliance with regulatory and GMP guidelines. • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues. • Perform other duties as assigned Basic Qualifications: • BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR • Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR • High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product). Preferred Qualifications: • BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. • Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards • Ability to effectively negotiate and build collaboration amongst individuals • Strong teamwork and collaborative skills • Experience with manufacturing investigations, deviations, and CAPA. • General knowledge of aseptic manufacturing processes. • Proficient in MS Word, Excel, Power Point and other applications. • Strong interpersonal, verbal and written communication skills • Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities • Willingness to think outside of the box and adapt best practices to a small, but growing environment • Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Thank you! Vishnu Kaushik Email: [email protected] Phone - 678-207-5230 PAY RANGE AND BENEFITS: Pay Range*: $35 - $40 per hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
QA Specialist - 3rd shift
American Cybersystems, Inc., Skokie
Innova Solutions is immediately hiring for a Quality Assurance Specialist - 3rd Shift Position type: Full-time Permanent position Location: Skokie, IL Pay Range: 3rd Shift $20/hr PRIMARY RESPONSIBILITIES Responsible to report any food safety and quality problems to personnel with authority to initiate action. Perform QA in-process inspections for each department/line once per shift by checking the following: production paperwork, retain sample, code date/lot number/best by date, weight check documentation, metal detection documentation, label, color code, department cleanliness employee GMP practice and checking for any potential allergen cross-contamination Perform scale checks once per day Place on hold materials due to quality, food safety per Hold Policy Send out electronic hold reports to through SharePoint and transfer PQ product to 100# Release products which are on hold when approval is received Generate disposal reports for materials on hold to be disposed Perform metal detector check as an audit during production Perform verifications on DVU - (2 Log and 5 Log) Perform alarm checks for roasters Perform changeover validation on production lines and perform clean equipment/ATP swabbing on equipment after sanitation policy 6615 Perform environmental swabbing during manufacturing policy 6614 Perform yearly allergen validation policy 6605 Maintain inventory of QA supplies Make retain samples for Production Conduct internal plant audits Conduct glass and brittle plastic audit Perform magnet pull test annually Perform metal detection test on metal detectable ear plugs and band aids twice a year Monitor GMP on the floor and send out daily report of issues noted Train new QA Techs and QA Specialists Generate maintenance work requests Shut down lines/department when a serious food safety issue is noticed Filing QA documents Conduct any other functions as required by the QA department Check oil FFA and water chlorine Candidates must have good communication skills and great attention to detail. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! [email protected] PAY RANGE AND BENEFITS: Pay Range*: 3rd Shift $20/hr *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
QA Specialist - 2nd
American Cybersystems, Inc., Skokie
Innova Solutions is immediately hiring for a QA Specialist - 2nd Shift Position type: Full-time Permanent position Location: Skokie, IL Pay Range: 2nd Shift - $19/hr - 3rd Shift $20/hr PRIMARY RESPONSIBILITIES Responsible to report any food safety and quality problems to personnel with authority to initiate action. Perform QA in-process inspections for each department/line once per shift by checking the following: production paperwork, retain sample, code date/lot number/best by date, weight check documentation, metal detection documentation, label, color code, department cleanliness employee GMP practice and checking for any potential allergen cross-contamination Perform scale checks once per day Place on hold materials due to quality, food safety per Hold Policy Send out electronic hold reports to through SharePoint and transfer PQ product to 100# Release products which are on hold when approval is received Generate disposal reports for materials on hold to be disposed Perform metal detector check as an audit during production Perform verifications on DVU - (2 Log and 5 Log) Perform alarm checks for roasters Perform changeover validation on production lines and perform clean equipment/ATP swabbing on equipment after sanitation policy 6615 Perform environmental swabbing during manufacturing policy 6614 Perform yearly allergen validation policy 6605 Maintain inventory of QA supplies Make retain samples for Production Conduct internal plant audits Conduct glass and brittle plastic audit Perform magnet pull test annually Perform metal detection test on metal detectable ear plugs and band aids twice a year Monitor GMP on the floor and send out daily report of issues noted Train new QA Techs and QA Specialists Generate maintenance work requests Shut down lines/department when a serious food safety issue is noticed Filing QA documents Conduct any other functions as required by the QA department Check oil FFA and water chlorine Candidates must have good communication skills and great attention to detail. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you!PAY RANGE AND BENEFITS: Pay Range*:1st Shift - $18/hr, 2nd Shift - $19/hr - 3rd Shift $20/hr *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
QA Specialist, Radiology (Clinical Educator)
Brigham & Women's Hospital(BWH), Boston
Reporting to the Assistant Clinical Director (ACD) of X-Ray, the Quality Assurance (QA) Specialist facilitates the X-Ray QA program and provides appropriate education and guidance to staff which includes assessing, planning, implementing, and evaluating both orientation and continuing education programs to enhance the quality of patient care services. The QA Specialist ensures these programs are based on the principle of delivering care appropriate to all ages of the patients served in the department. Responsible for overseeing and leading regulatory and accreditation processes where applicable. Collaborates with department leadership to develop, implement, and evaluate learning opportunities appropriate and as indicated for students, new employees, and incumbent staff. The individual must have proven problem-solving skills to provide effective and professional guidance and training. Principal Duties and Responsibilities Works regularly in all areas of department as X-Ray Technologist to maintain optimal direct patient care and imaging skills as well as exemplify expected work behavior for all students and technologists; Maximizes opportunity to teach students and other Technologists in real time while working on floor Responsible for the development and delivery of staff and student education, training in patient care areas and conducting classroom/lecture activities; Regularly presents in departmental staff meetings/scheduled in-services to educate with intent to improve departmental knowledge and performance Responsible for student performance, including but not limited to regular instruction, both classroom and clinical, monitors student attendance, performance, and interaction with staff; Seeks feedback from incumbent staff and follows up accordingly; Ensures equity in student clinical experience and rotations; Completes performance evaluations; Acts as BWH Representative in all interactions with formal education programs Collaborates with Clinical Managers/Lead Technologists to orient new employees, coordinates training; Follows up on feedback as result of new employee/incumbent employee performance with intent to train or re-train to expected employee performance Assists ACD and Clinical Managers with assessment of technologist initial and annual competency for performance evaluations as needed; Develops corrective action plans as needed Demonstrates proficient to expert knowledge of all imaging equipment, techniques, procedures, and inventory Maintains appropriate education documentation including staff competencies and licensure Collaborates and participates with research teams to meet protocol requirements and conduct appropriate staff education/monitor progress Collaborates with staff, radiologists, and department leadership to ensure exam protocols, patient care processes, and image quality are optimized Collects and analyzes quantitative and qualitative statistical data as requested for departmental projects, maintains properly operating equipment, and works with vendors to resolve technical problems Collaborates with the ACD to maintain quality assurance in accordance to all relevant regulatory and accrediting bodies Performs other duties as assignedQualifications Must be a graduate of an approved School of Radiologic Technology; possess a current permanent Massachusetts License in Radiography, and current registration and certification by the American Registry of Radiologic Technologists (ARRT) or equivalent in the specific imaging modality as required by State licensing and national certification and registration regulations3 - 5 years' progressive experience as an Imaging Technologist in Radiography required; Teaching or Clinical/Adjunct Instructor experience is preferredAssociates Degree is required. Bachelor's Degree is preferredSkills/Abilities/Competencies Required:Comprehensive understanding of relevant information systems involved with Medical ImagingPossess an advanced knowledge of X-Ray and its associated principles, imaging procedures, techniques, and equipmentPossess effective communication and interpersonal skills to positively interact with students, technologists, radiologists, and other department leadership (physicists, Q&S, etc.) to develop a superior quality assurance program, enforce department policies and procedures, as well as to provide comfort and instruction to patients and their familiesMust possess analytical abilities necessary to acquire and effectively utilize knowledge of imaging processes, techniques and proceduresMust be prepared to be an engaged and enthusiastic instructorFunction appropriately in emergency or delicate situations, maintaining composure and discretionMust be aware of hazards within the department (ionizing radiation, standard precautions, etc.), and adhere to safety standards established by BWH and regulatory agenciesPresents a positive attitude and a professional appearance to exemplify the profession and represent the departmentMust demonstrate flexibility and willingness to adapt to diverse roles as a member of the department teamMust have the ability to adapt to changing pace within the department; expect and anticipate frequent interruptionMust be able to provide own transportation to travel between BWH main campus and off campus imaging (OCI) sites if needed for staff in-service or as indicated for clinical coverageWorking Conditions:Ability to travel to/from and between imaging sites as required.Will be asked/required to cover shifts as a Radiologic Technologist.Works in a large open area in Radiology which is noisy and tends to have extreme temperature and humidity variations.Minimal exposure to ionizing radiation when using proper safety procedures.Continuous standing and lifting.Exposure to human waste and disease.Considerable stress from dealing with a wide variety of hospital staff, patients, and familiesEEO Statement BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Senior QA Specialist
US02 Lonza Biologics Inc., Portsmouth
 Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.The Sr QA Specialist, through their increased knowledge and proficiency, assists GMP associates by providing first response and real-time Quality Assurance support for operational areas directly or indirectly involved in the execution of GMP-related activities. This role serves as a resource to less experienced team members. Key responsibilities include batch record review (paper and electronic), logbook review, analytical testing review, Quality Tag Outs, release of areas and equipment from product changeover and other GMP records as applicable, as well as coaching & mentoring the associates with GMP tasks.The Sr QA Specialist acts as the eyes and ears of Quality Assurance within operational areas, helping to ensure that the facility is inspection ready and GMP operations and documentation are in compliance.Key Responsibilities:Perform the daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits. Provide some coaching and feedback for GMP and documentation behaviors, working with Manufacturing ManagementProvide GMP guidance to Manufacturing for routine and non-routine issues. May elevate more complex issues to senior staff and ManagementRespond to QA Hotline calls in support of GMP operations. Sr QA Specialist is able to make most simple GMP decisions independently. With some complex decision making, they are working with senior staff or managementProvide guidance and compliant decision making to junior staffDocument all items within QAOTF shift notes, provide follow-up for other shifts as needed.Authorize placement and removal of Quality Tag Outs, release equipment from Product ChangeoverOversee label management including creation and issuance of final product labelsRepresent QA in meetings or on project teams as sole department representative. Will gain buy-in on QA positions and commitments from senior staff and/or ManagementPerform other duties as assignedKey Requirements:Degree in Life Sciences and/or relevant experience in a Quality Assurance Environment5+ years of experience in roles of increasing responsibility within QualityHas solid understanding of cGMP and ICH guidelines and requirementsMust possess a working knowledge and understanding of critical process steps and parameters - e.g. final product filling, cryopreservation, aseptic processingUnderstands the concept of product clearance through process changeoverKnows the concept of deviation management and documentationUnderstands the TrackWise, SAP, LIMS, SAP, Syncade and Microsoft Office systemsIs able to identify and act on situations which require escalation; Can recognize an abnormal or potentially impactful event and knows whom to elevate toEvery day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 
QA Specialist - Night Shift
Continental Mills, Inc., Kent
Position available on 12 hour night shift The policy of The Krusteaz Company is to hire, train, and promote all persons in all job groups in accordance with law, without regard to race, color, religion, sex, sexual orientation, age, marital or military status, national origin, gender identity, the presence of any sensory, mental or physical disability, genetic information, or any other status or characteristic protected by local, state, or federal law. Get to know us: A people-focused company that cares​: We’re a 90-year-old company with the entrepreneurial spirit of a startup and a focused eye on the future. As a midsized, privately-held company with a portfolio of beloved food and beverage brands, our people are the most important ingredient in our success. A valued and supported workforce​: We place tremendous value in our employees and provide competitive pay and comprehensive benefits to ensure our employees can create the best life for themselves. Benefits include a top tier health insurance plan with lower than average employee cost share, generous PTO, 401(k) match, and more. An engaged and energized culture​: At The Krusteaz Company, collaboration and ingenuity drive our fierce commitment to creating extraordinary product experiences that people love. A place to grow and make a difference: An entrepreneurial spirit has been at the core of our company since the beginning, attracting self-starters who are curious and love to learn and to share ideas.   Benefits: We are proud to offer generous benefits including comprehensive medical, dental and vision insurance (starting at $45/month for employee only coverage), 401(K) matching, 3 weeks of paid vacation, 10 paid holidays, company provided life insurance and disability insurance, flexible spending account and tuition reimbursement.   Salary Information: An employee in this position can expect a salary range between $66,257 and $96,414. We typically pay out between $66,584 and $84,601. The actual salary offered will carefully consider a wide range of factors, including internal equity, experience, education, certification, training, and location. All positions are eligible for additional incentives based on business performance.   About the Position The QA Specialist position provides leadership and technical QA support to the manufacturing facility in the areas of qualify and food safety. This will involve coordinating activities, providing resource support for diverse teams with complementary objectives, identifying key opportunities, providing technical training, and leading initiatives to improve food safety, quality and regulatory compliance. Essential Functions Other duties, responsibilities, and activities may change or be assigned at any time. Proficient technical resource for product quality and food safety, coordinator of new products, changes, plant trials and materials. Coordinates customer expectations from Sales and R&D with manufacturing capabilities. Facilitates and leads continuous improvement activities for people, processes and product systems. Leads problem solving teams to identify and resolve root cause issues. Understands the plant operations and the critical processing points for product safety, consistency and efficiency. Leads the transformation of data, through key performance indicators, into meaningful information to make business decisions. Develops, implements and monitors standard operating procedures for quality systems. Provides QA training support to the manufacturing team and other internal and external customers. Recommend product rework options and/or formulation changes Provides leadership and development training to the Quality Technicians. Successfully performs routine product testing activities and other duties of the QA lab. Ensures plant compliance with GMP’s, HACCP, third party audits and other state/federal regulations May supervise a small team of non-exempt employees or back up QA management as needed May evaluate and investigate customer complaints   Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions. Enjoys facilitating change and leading improvement efforts. Effectively provides direct and indirect leadership to people, projects, and activities. Strong technical skills in the area of food / bakery science including knowledge of ingredient interaction and application. Solid background in development and improvement of fundamental manufacturing and quality-related systems. Demonstrated ability to manage multiple tasks and priorities. Understands and uses computer software, including MS Office, inventory management, and other proprietary and database software to manage data for decision making. Professional demeanor and strong interpersonal skills. Strong math, reading, sensory, technical writing and verbal communication skills. Demonstrated ability to solve problems.   Supervisory Responsibilities While performing as an individual contributor, may also provide daily supervision to non-exempt employees in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing and training employees; planning, assigning, and directing work; and appraising performance, but typically will not include hiring and disciplining employees.   Education and/or Experience Associates degree or minimum two years of college level coursework, preferably in Food Science, Biology, Chemistry or related field or equivalent experience; Bachelor’s degree or equivalent experience preferred. Minimum of 3 years’ experience in quality assurance and/or 2 years leadership experience in food manufacturing and quality assurance desired Experience with food safety and audit requirements such as BRC preferred.   Schedule Rotating 12 hour night shift working 6:00 PM - 6:30 AM scheduled 3 or 4 days per week. Some flexibility required as needed.    Attendance To support ongoing business goals and successfully contribute to your team, acceptable levels of performance and attendance must be consistently maintained, including attending all required meetings and events. Requires the flexibility to work non-standard hours as needed.   Quality Follows procedures to ensure all food quality standards are met or exceeded. Must also produce quality work measured by efficiency, accuracy, and completion of both personal and company goals in a manner that embodies CM values and our culture of integrity, dignity and respect.    Safety/Legal Employees are required to conduct their work in a safe and legal manner, according to all GMP food safety standards as well as following any safety protocols. Employees must be willing to be responsible for their safety and health as well as the safety and health of all employees, vendors and visitors.   Physical Demands and Work Environment This position requires working in both manufacturing and office environments. While performing the duties of this job, the employee is regularly required to stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone along with reaching. Specific vision abilities include close vision requirements due to computer work. Moderate noise, ability to work in a confined area, and ability to sit at a computer for an extended period of time are also included. Must be able to effectively communicate and work in a dynamic environment. You may also be on your feet for several hours a day and may be exposed to a variety of physical demands that require you to lift heavy objects, climb stairs, exert energy, bend, twist and squat and use tools and equipment in an indoor production environment that has a high level of food dust and limited climate control while wearing PPE. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. This position description is designed to outline primary duties, qualifications and job scope, but not limit our employees nor the organization to just the work identified. It is our expectation that each employee will offer his/her services wherever and whenever necessary to ensure the success of the company. The policy of Continental Mills, Inc. is to hire, train, and promote all persons in all job groups in accordance with law, without regard to race, color, religion, sex, sexual orientation, age, marital or military status, national origin, gender identity, the presence of any sensory, mental or physical disability, genetic information, or any other status or characteristic protected by local, state, or federal law. See job description
Content Producer + QA Specialist
Chegg, Inc., Lincoln
Job DescriptionContent Producer + QA SpecialistAs a Content Producer/QA Support on the Instructional Design and Development team at Chegg Skills, you will be instrumental in helping ship new and updated curriculum to our learners. In this role, you will provide content production and quality assurance support in our ecosystem of tools and across our catalog of disciplines. You will become a backend superuser of the curriculum-building tools that house our materials, and you'll be responsible for the nitty-gritty, tactical steps in the publishing process. You'll also conduct reviews of shipped content to ensure the student experience is what we'd expect.This work will span a variety of production, editorial, quality assurance, administrative, and operational tasks to help ensure all the content (text, visual assets, supplementary materials, etc.) is built, migrated, and published properly. You'll be expected to develop a technical understanding of our tools and have strong communication skills, a keen eye for detail, and a passion for tips and tricks that drive consistency within content with multiple authors.This role will report into the Technical Content Coordinator and work closely with others on the Content Operations team and the broader Instructional Design team. This will be a 6-month contract with high likelihood of extension.ResponsibilitiesQuickly learning and working in our suite of curriculum-publishing tools (CMS, homegrown LMS, assessment software, etc.) and developing a deep understanding of the technical contingencies, approval flows, and validation logic of our platformsOwning the tactical production and publishing of content across our catalog and providing the Technical Content Coordinator with information for weekly release notes/updatesDownloading, uploading, inputting, and renaming assets, files, and artifacts in our content management systemProviding content-based quality assurance support, which includes a comprehensive review of how content is rendered within the student learning environment(s) to ensure all components of the curriculum behave as expectedQuickly understand and consistently apply the conventions in our editorial house style guide for any minor editorial work requiredWhen appropriate, making fixes to resolve content-based bugs in our curriculumSupport Technical Content Coordinator on documenting and facilitating trainings on processes for building, migrating content to, and/or publishing new or adapted learning componentsOrganize and enable cross-catalog updates in response to emerging business needs and prioritiesSupport Content Operations team on process changes; identify pain points and problems inhibiting efficient or quality content production or maintenanceWorking in our suite of project management and collaboration tools (MS suite, Slack, Jira, Confluence)As needed, help support the media production pipelineAs needed, collaborate with the Content Ops team and instructional designers to understand and prioritize curriculum updates - helping determine the scope of changes, set realistic dates for curriculum release, and manage the completion of editorial, QA, and publishing tasks to meet deadlinesRequirements3+ years of experience in a role that blends digital content production and project management; could be web or digital content manager, content producer, LMS or CMS administrator, media editor, managing editor, or adjacent roleFamiliarity with and comfort engaging with a CMS or LMS; previous experience working with specialized content and configurations.A nice-to-have: experience working in curriculum design, edtech, education, tech bootcamp, or similar tech or tech-adjacent space.Ability to work independently, meet deadlines, and handle multiple projects simultaneously.Excellent communication and collaboration skills, particularly in writing.Exceptional time-management and organizational skills.Experience working as an editor or in quality assurance; should have strong editorial instincts and an eye for detail.Strong attention to detail and commitment to maintaining content accuracyAbility to adapt to evolving industry standards and technologies.Flexible hours to accommodate varying workloads.Why do we exist?Students are working harder than ever before to stabilize their future. Our recent research study called State of the Student shows that nearly 3 out of 4 students are working to support themselves through college and 1 in 3 students feel pressure to spend more than they can afford. We founded our business on provided affordable textbook rental options to address these issues. Since then, we've expanded our offerings to supplement many facets of higher educational learning through Chegg Study, Chegg Math, Chegg Writing, Chegg Internships, Thinkful Online Learning, and more to support students beyond their college experience. These offerings lower financial concerns for students by modernizing their learning experience. We exist so students everywhere have a smarter, faster, more affordable way to student.Video ShortsLife at Chegg: http://youtu.be/Fwf90zgaOLACertified Great Place to Work!: http://reviews.greatplacetowork.com/cheggChegg Corporate Career Page: https://jobs.chegg.com/Chegg India: http://www.cheggindia.com/Chegg Israel: http://www.chegg.com/about/working-at-chegg/israel/Thinkful (a Chegg Online Learning Service): https://www.thinkful.com/about/#careersChegg out our culture and benefits!http://www.chegg.com/about/working-at-chegg/benefits/http://techblog.chegg.com/Chegg is an equal opportunity employer
QA Specialist
Actalent, Saint Louis
Description:Quality Assurance Specialist - Quality Systems, supports all quality system elements to assure compliance with FDA cGMP and other quality standards, with primary responsibilities in Annual Product Reviews, Change Controls, and Product Labeling Changes. Provide quality oversight for the creation and revision of labeling components, including participation on the Label Review Team.Compile data and write Annual Product Reviews.Support of the Change Control Process, including participation on the Change Control Review Board.Support training program, including New Employee Orientation Program and annual GMP training schedule.Provide necessary documentation to Regulatory Affairs, as requested (i.e., in support of MCSRs).Review regulatory filings and submissions, as requested.May also participate in other Quality Systems responsibilities including: Tracking and Trending of Quality Data, Training, Supplier Quality Management, as well as internal and external audits. Support site Data Integrity requirements.Provide metrics for the Quality Review Board, as requested.Provide support during HACCP, FDA, and other inspections.Support Supplier Qualification Program.Support updates to the Approved Vendor/Supplier list.Perform Internal and External Audits per annual audit schedules.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.
QA Specialist
Renaissance LLC, Lakewood
Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.QA SpecialistUS-NJ-LakewoodJob ID: 2024-2746Type: Regular Full-Time# of Openings: 1Category: QualityLakewood, NJOverviewTo review manufacturing batch records, testing results and deviation reports for compliance with cGMP and company procedures with minimal supervision. To release products, drug product components and container-closures. To review and write cGMP procedures under supervision. To report periodic quality metrics.ResponsibilitiesReview manufacturing batch records, testing results and deviation reportsInteract with other departments to address review observationsRelease drug product, drug product components and container-closuresInteract with customers on batch record reviews and batch releasesAttend department meetings on batch record review and releasesMaintain and report quality metrics on batch record review and releasesReview and write standard operating proceduresReview quality system documents (change controls, validation, complaints)Review master batch records and maintain recordsProcess, investigate and follow-up on product complaintsEnsure quality and timely review of notifications, deviations and CAPAs; both commercial and developmentFinal closure and delivery of PRs to the clientCreation of, follow up and closure of CAPAsEnsure extensions for PRs are completed adequatelyWork with other departments to ensure quality and timeliness of deviations/notificationsLead triage and notify clients of new PRsAttend/host client meetings, prepare detailed agenda, communicate directly with client, manage client requests/follow up on documentsPrepare metricsPerform other tasks as requested by management. QualificationsBachelor’s Degree (BA or BS), preferably in a Natural Science, is required. A minimum of 3 years of relevant experience in the pharmaceutical industry is required. PI239847900
QA Specialist (Specialist / Senior Specialist / Principal Specialist)
AstraZeneca, Newark
Join us as a QA Specialist, where you'll handle QA activities that directly support the execution of the process within the Process Execution Team (PET) and in assigned areas outside of the PETs. This includes batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. Accountabilities:Our QA Specialist, maintain a high level of understanding of relevant production processes and quality systems. You'll perform the QA review and approval of GMP documentation related to processing equipment and facility. You'll collaborate with other Quality professionals across the organization to ensure consistent application and execution of key quality systems. You'll complete QA processes including batch record review, sampling and inspection of incoming materials, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives. Are you ready to assume these meaningful responsibilities?WORK SCHEDULE: 1st Shift, either Tues-Sat (8 hrs x 5) or Wed-Sat (10 hrs x 4)Essential Skills/Experience:QA Specialist:- High School (diploma/GED) and 2+ years of experience in GMP environment or - Bachelor's degree in relevant field of study with 0-1 years of experience- Strong ability and motivation to learnSr. QA Specialist:- Five (5) years experience in the pharmaceutical industry and/or FDA experience with at least three (3) years in Quality Assurance/Compliance.Principal QA Specialist:- Seven (7) years experience in the pharmaceutical industry and/or FDA experience with at least five years in Quality Assurance/Compliance.Desirable Skills/Experience:QA Specialist:- BS degree in Technical Field of Study w/3+ years working in a highly regulated industry.Sr. QA Specialist- 7+ years in QA/Regulatory Compliance in the pharmaceutical industry.When we put unexpected teams in the same room, we enable creative thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, the entire shift from the facility. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and bold world.Why AstraZeneca?With constant new products and launches, there's never been a better time to join Supply Chain at AstraZeneca and craft our future with a big contribution to life-changing medicines. Our resilience helps us to succeed as we innovate and evolve. We are a diverse, multigenerational team of authorities connected across the globe. We interpret the science, connecting it with the business need to apply manufacturing excellence. If you are tenacious, take sensible risks and are able to act quickly, then this is the place for you!Ready to make a big impact? Join us at AstraZeneca where our contribution to life-changing medicines is why people have been here for decades. We do it for the patients. Apply now!AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.