Quality Control Analyst II
As a member of the Quality Control Laboratories at New England Biolabs (NEB), the person in this position will be primarily responsible for performing QC testing to support the production and release of GMP-Grade enzymes and molecular biology reagents.
Primary Responsibilities:
- Perform raw material, in-process, stability and final product testing
- Organizing, reporting and trending test results
- Optimize and qualify test methods
- Drafting Quality documentation including: SOPs, test methods, change controls, deviations, CAPAs, protocols and reports
- Peer reviewing assays and other Quality documentation
- Initiate and participate in Laboratory and Out of Specifications (OOS) investigations
- Qualify critical reagents used in test methods
- Manage product archives and reference materials
- Maintain the QC laboratory and associated equipment
- Maintain up to date training file for the QC Department
Required Qualifications and Experience:
- B.S. degree in biology or related field
- Minimum 4 years’ experience working in a QC lab setting
- Strong knowledge of cGMPs
- Experience with laboratory techniques including: spectrophotometry, UPLC/HPLC, capillary electrophoresis, qPCR and compendial testing methodologies; micro testing experience is a plus
- Experience performing laboratory-based tasks, including: reagent preparation, sample management, testing and release of raw materials
- Have the ability to perform routine tasks accurately and follow strict methodologies to carry out analyses
- Possess strong recordkeeping skills and the ability to analyze, interpret and report results to senior staff
- Have strong interpersonal skills and the ability to effectively collaborate with others
- Have a working knowledge of MS Office applications
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.
OFCCP’s pay transparency policy can be found on OFCCP’s website at www.dol.gov/ofccp
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.