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