New England Biolabs (NEB) is seeking a Quality Control Associate to join the Quality Control Laboratories at our Rowley facility. The person in this position will be primarily responsible for performing GMP testing to support the production and release of enzymes and molecular biology reagents.
Optimize and qualifying test methods
Perform raw material, in-process and final product testing
Organize, reporting and trending test results
Draft Quality documentation including: SOPs, test methods, change controls, deviations, CAPAs, protocols and reports
Peer reviewing assays and other Quality documentation
Initiate and participating 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 an up to date training file for the QC Department
Qualifications and Experience:
B.S. degree in biology or related field.
Minimum 5 years’ experience working in a QC lab setting.
Strong knowledge of cGMPs.
Experience with laboratory techniques including: spectrophotometry, electrophoresis, qPCR and comendial 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.
New England Biolabs is an Equal Opportunity/ Affirmative Action Employer of Minorities, Females, Disabled and Protected Veterans