QA Specialist Salary in USA

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.

 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.Lonza Tampa is seeking an experienced professional who assists and supports the organization with initial compliance and ongoing preparation, and monitoring of conformance to established quality assurance processes and standards. A qualified candidate conducts internal production/process and manufacturing quality control audits and risk assessments. Role reports to QA Compliance.Key Accountabilities:Performs document reviews of SOP’s, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures.  May also review raw materials, work orders, validation and MSAT reports.  Independently writes SOPs or associated documentation.Independently approves SOPs, customer audit and regulatory CAPA.Works with technical transfer teams to prepare new processes; act as responsible QA designee Approves Laboratory Data and Reports.Assesses potential impact to product quality for open deviations during lot release. Review for compliance of change controls, CAPA, investigations, deviations and OOS.Lead complaint management processParticipates in investigations into root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity. Problem solving ability to resolve basic to moderate quality issuesLeads internal and external audits, and tracks audit and inspection commitments.Independently hosts customer audits or leads a team during regulatory inspections Creates and presents training seminars on cGMP issuesOwns and leads special projects, often complex in nature    Makes recommendations of changes to processes and programs. Trains new team members.Performs additional job-related assignments as requested by managementAdhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclearPromptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possibleStop work where deemed necessary to maintain safetyBasic computer skills and preference for experience with Trackwise, SAP, DocumentumKey Requirements:Bachelors degree in ScienceMinimum of 5 years' experienceSignificant experience in cGMP pharmaceutical setting preferably oral solid dosageEvery 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.

If you're a medical professional skilled in reviewing and interpreting medical records, driven by a passion for aiding others, we're eager to connect with you! We are seeking a Medical Quality Assurance (QA) Specialist to support our Veteran Affairs Operations in San Antonio, TX    Who is Leidos QTC Health Services? We are the nation’s largest provider of disability and occupational health examination services. We are PASSIONATE about our country’s veterans, UNITED as a team and INSPIRED to make a difference. To provide high-quality, timely, and customer-focused medical examination service solutions, we honor our core values of integrity, innovation, agility, collaboration, inclusion and commitment. We celebrate diverse thinking and welcome contributions from all. What part would you play in this role? As a Medical QA Specialist, you will work closely with medical providers and the Veterans Administration to ensure the documentation process is complete and accurate. In this role, you will review documentation sent over from medical providers and ensure the report is complete, concise, clear, and correct and the provider has accurately completed the Disability Benefit Questionnaires for delivery back to the VA. In this rewarding role, you will: Review exam reports sent over from medical providers Ensure all medical coding is complete and accurate Ensure all tests have been ordered and completed, and present in the medical record Coordinate with medical providers as needed for clarification of reports Work with our in house appointment schedules to request additional appointments for the veteran as necessary Learn more from one of current QA's here! You must have: High School diploma or equivalent; advanced medical training preferred.  Strong knowledge and understanding of anatomy and medical terminology Ability to read and analyze medical reports Ability to apply clinical reasoning (diagnostic testing) Ability to write clear questions to submit to the provider Experience working with medical providers (credentialing, medical coding, chart audits, triage, scribe, nursing) Preferred to have: Allied medical professional certification, or relevant college, or vocational training in the medical field, i.e. LVN, CNA, Military Corpsman/Medic, EMT, MA, etc. Experience assisting with medical tests, treatments and procedures  Knowledge of military medical examinations or experience working with the VA Knowledge of general disability claims, workers compensation, or audits This is a great role for: Military Medics or Corpsmen Medical Scribes CNA / CCMA / LVN / LPN / RN EMT / Paramedic Lab Tech / Pharmacy Tech Medical Records Analyst Typical Day: Mon – Fri: 8:00am – 4:30pm CST Positions are located ONSITE at our San Antonio, TX office located at 4400 N.W. Loop 410, Ste. 500 San Antonio, TX 78229 Pay and Benefits: Starting pay: $ 19.95 per hour with an increase after training. The Leidos QTC Health Services' pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to): geographic location, responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. As a result, we offer meaningful and engaging careers to support you and your career goals, all while nurturing a healthy work-life balance. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here. Commitment to Diversity Leidos QTC Health Services Management is a VEVRAA Federal contractor and an Equal Opportunity Employer. The company has an ongoing commitment to affirmative action and the creation of a workplace free of discrimination, harassment and retaliation. The company recruits, hires, trains, and promotes individuals in all job titles without regard to race, color, creed, religion, ancestry, national origin, age, sex, sexual orientation, people with disabilities protected under law, and  protected veteran status. * This job description supersedes all prior job descriptions and is intended to describe the general content and essential requirements for the position listed above. It is not to be construed as an exhaustive statement of requirements, duties and responsibilities. Management reserves the right to add or change the duties of this position as required at any time.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Administrative/Technical

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.

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.

TransCore (TRN), a subsidiary of ST Engineering, Inc. is seeking a full-time temporary Associate Quality Assurance Specialist to join our team in Raleigh, NC. Summary: The Associate Quality Assurance Specialist is an entry-level position and a position whose primary responsibilities are to look for flaws and weaknesses in compliance with the system requirements, documentation work products, system functionality, and system performance using auditing and systematic tests; Support the project team to develop, apply, and maintain quality standards for company products; Modify and execute test plans; Document processes, practices, test standards, and procedures; Maintain documentation to assist in product and process defect tracking and resolution. Qualifications: 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 disabilities to perform the essential functions. Essential Duties and Responsibilities: include the following. Other duties may be assigned. Daily issue tracking - including maintenance, triage, analyze, assign, Modify and execute software test scripts created from functional specifications, Maintain test results to help in debugging of software, Provide quality assurance support throughout the life cycle for development projects and maintenance activities. This includes executing quality control techniques such as requirements tracing, walkthroughs, risk management, system testing, automated testing, and validation, Implement quality goals and metrics that quantify product quality during development and in production, Participate in quality control activities ensuring that resources (people, hardware, software) are available, activities are executed, results are evaluated, exceptions are recorded and managed. Education and Qualification: High school diploma or general education degree (GED) required. Required Technical Skills & Competencies, include the following but are not limited to: Typically requires a minimum of 0-2 years of related experience, Proficiency with Microsoft applications (Office/Word/Outlook/etc.) Currently have and successfully maintain an active, valid driver's license, Must be willing and able to work outdoors in various weather conditions; work overtime, weekends, and holidays as needed and required, in the support of the Project Team, Ability to interact with field staff, Management, Client, and Vendors, Ability to work under pressure and meet deadlines, Ability to read, write, analyze, and interpret general business correspondence, technical procedures, and procedure manuals, Ability to define problems, collect data, establish facts, draw valid conclusions, and interpret an extensive variety of technical instructions, Uses skills as a professional with understanding of processes; implements/audits procedures; and resolves issues in practical ways. Desired Technical Skills & Competencies: Infinity Product Operational Knowledge Basis coding/scripting. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle, or feel. The employee is frequently required to reach with hands and arms and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision. Constant use of computer monitors from 20 inches or less. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. All job duties are performed in a business office setting.

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.

Job DescriptionCOMPANY INFORMATIONThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com. GROUP/DIVISION SUMMARYThe Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.POSITION SUMMARYIn this position, you'll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours would be 6A-6p, on a 2-2-3 rotating shift.Key Responsibilities:Provide In-Line batch quality record reviews in the Steriles Packaging and Inspection Production areas.Perform document reviews and make determinations as to whether work performed meets current procedures and regulatory expectations. Communicates and coordinates with other departments to resolve issues and compliance concerns detected during review.Daily interaction with personnel to assist with troubleshooting, documentationPerform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance per site procedures and cGMPs.Provide corrections/notes, and guidance with aseptic techniqueCultivate quality culture by aiding personnel in understanding application of policies and controlsParticipate in rapid response and provides quality guidance and quality decision making for RAPID eventsAdvance deviation events to the appropriate area and quality supervisionAid in identification of continuous improvement opportunities; Participates in practical process improvement initiativesQualifications:Associates degree in science, technology, engineering, mathematics (STEM) or business with 4 years of experience in Quality Assurance, Quality control or Operations/Manufacturing required.Bachelor's degree in science, technology, engineering, mathematics (STEM) or business, with 2 years of experience in Quality Assurance, Quality control or Operations/Manufacturing required.Equivalent combinations of education, training, and relevant work experience may be considered.Experience and knowledge in aseptic or steriles processes, preferable.GMP's process in an aseptic area and review batch record.Quality and compliance understandingAbility to collect data, analyze and troubleshoot process issues, equipment problems along with production leadershipDetermined, proven ownership and responsibilityAbility to lead, support and motivate a teamTechnical Writing experienceProfessional certifications (ex: CQA) and training (Six Sigma) are a plusPosition requires 12 hour day shift schedulePhysical Requirements:Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.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. 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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 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.Skills:Quality assurance, Annual product review, label, change control, Gmp, Fda, quality systems management, pharmaceutical, AuditTop Skills Details:Quality assurance,Annual product review,label,change control,GmpAdditional Skills & Qualifications:Bachelor's degree strongly preferred; Degree in Biology, Chemistry or related field of study preferred3 - 5 years of experience in a FDA regulated pharmaceutical facility preferred3 - 5 years of experience in Quality Assurance / Quality SystemsIdeally will have exposure and experience with one of the primary areas of responsibility (supporting Label Changes, Change Controls, APR's)Experience Level:Intermediate LevelAbout 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.

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 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.Additional Skills & Qualifications:Bachelor's degree strongly preferred; Degree in Biology, Chemistry or related field of study preferred3 - 5 years of experience in a FDA regulated pharmaceutical facility preferred3 - 5 years of experience in Quality Assurance / Quality SystemsIdeally will have exposure and experience with one of the primary areas of responsibility (supporting Label Changes, Change Controls, APR's)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.