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Quality Control Manager

Company: New England Biolabs, Inc.
Location: Rowley
Posted on: September 24, 2022

Job Description:

New England Biolabs (NEB) is seeking a Quality Control Manager to oversee the QC Laboratory at our Rowley, Massachusetts facility. This NEB site manufactures GMP Grade reagents used by customers to produce therapeutics products and/or in vitro diagnostics. The individual in this position will oversee and participate in day-to-day work operations in the QC lab and ensure documentation is completed in accordance with ISO and GMP requirements. Exceptional organizational skills are required to manage samples, test results and documentation. Primary responsibilities: Overall management of the GMP QC Lab Operation Manage a team of QC Technicians Oversee equipment maintenance and calibration Oversee third party raw materials and product testing Oversee sampling and QC testing on incoming critical raw materials, as needed Perform in process and final QC assays for enzymes or molecular biology reagents Investigate and document out of trend and out of specification test results Oversee and document lab deviations and investigations Disposition of nonconforming raw materials, intermediates and final product Manage internal and external method qualification and/or transfers Support CAPA and other Quality Management System requirements Create and/or revise QC lab SOPs and STMs Provide training to QC Technicians Control QC laboratory documents and records including test methods, specifications notebooks, and logbooks Validation of QC instruments and test methods Establish and implement the Environmental Monitoring and Clean Utilities Monitoring programs Manage reference materials, product retains and stability samples Perform or oversee routine environmental monitoring and cleaning validation studies Assist in customer and/or regulatory audits Required Qualifications and Experience: Bachelor's degree required in chemistry, biology or related field; advanced degree preferred Minimum 7-10 years' relevant experience Minimum 2 years of direct supervisory experience Have a working knowledge of cGMP standards, regulatory compliance (US and other international agencies) and ISO 13485 Quality Management Systems Have in-depth understanding of cGMP-regulated quality control responsibilities and analytical methods including qualification and transfer of methods Experience performing microbial testing under USP , and Experience in environmental monitoring Have good hands at the bench and an ability to perform careful and consistent experiments Have expertise in enzyme activity assays, protein characterization and quantification, UPLC, qPCR, CE, PAGE, and agarose gel electrophoresis Possess the ability to perform statistical analysis and trending of data Have strong interpersonal skills and the ability to effectively collaborate with others Have excellent people management skills Have a working knowledge of MS Office applications including validation and control of Excel spreadsheets Familiarity with SAP, SharePoint, ELN, TrackWise, and laboratory information management system (LIMS) a plus NEB currently requires all employees located in the United States to be fully vaccinated against COVID-19. New hires must be fully vaccinated prior to the first date of employment. NEB will consider requests for reasonable accommodations, as required by applicable law. EEO Statement New England Biolabs is committed to fostering a diverse and inclusive community; as an EEO/AA employer, New England Biolabs considers applicants for employment without regard to, and does not discriminate on the basis of, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability. More in-depth details of EEO are available here. Information regarding New England Biolabs commitment to Diversity, Equity and Inclusion can be found here. New England Biolabs is a participating employer in the Employment Verification (E-Verify) program. If you need an accommodation for any part of the employment process because of a medical condition or disability, please send an email to hr@neb.com or call 978-927-5054 to let us know the nature of your request.

Keywords: New England Biolabs, Inc., Lynn , Quality Control Manager, Executive , Rowley, Massachusetts

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