Quality Control Manager

Company: New England Biolabs, Inc.
Location: Rowley
Posted on: January 23, 2023

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 OperationManage a team of QC TechniciansOversee equipment maintenance and calibrationOversee third party raw materials and product testingOversee sampling and QC testing on incoming critical raw materials, as neededPerform in process and final QC assays for enzymes or molecular biology reagentsInvestigate and document out of trend and out of specification test resultsOversee and document lab deviations and investigationsDisposition of nonconforming raw materials, intermediates and final productManage internal and external method qualification and/or transfersSupport CAPA and other Quality Management System requirementsCreate and/or revise QC lab SOPs and STMsProvide training to QC TechniciansControl QC laboratory documents and records including test methods, specifications notebooks, and logbooksValidation of QC instruments and test methodsEstablish and implement the Environmental Monitoring and Clean Utilities Monitoring programsManage reference materials, product retains and stability samplesPerform or oversee routine environmental monitoring and cleaning validation studiesAssist in customer and/or regulatory auditsRequired Qualifications and Experience:Bachelor's degree required in chemistry, biology or related field; advanced degree preferredMinimum 7-10 years' relevant experienceMinimum 2 years of direct supervisory experienceHave a working knowledge of cGMP standards, regulatory compliance (US and other international agencies) and ISO 13485 Quality Management SystemsHave in-depth understanding of cGMP-regulated quality control responsibilities and analytical methods including qualification and transfer of methodsExperience performing microbial testing under USP , and Experience in environmental monitoringHave good hands at the bench and an ability to perform careful and consistent experimentsHave expertise in enzyme activity assays, protein characterization and quantification, UPLC, qPCR, CE, PAGE, and agarose gel electrophoresisPossess the ability to perform statistical analysis and trending of dataHave strong interpersonal skills and the ability to effectively collaborate with othersHave excellent people management skillsHave a working knowledge of MS Office applications including validation and control of Excel spreadsheetsFamiliarity with SAP, SharePoint, ELN, TrackWise, and laboratory information management system (LIMS) a plusEEO StatementNew 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 or call to let us know the nature of your request.

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