Location: Rowley, MA United States
As a member of the Quality Control Laboratories at New England Biolabs (NEB), this individual is primarily responsible for managing transfers and routine testing at Contract Testing and Manufacturing Organizations, performing testing to support the production and release of enzymes and molecular biology reagents. The successful candidate will have expertise in liquid chromatography techniques (e.g. UPLC, UHPLC, HPLC...etc.) and capillary electrophoresis and work closely with a team of QC Analysts focused on these methods.Primary Responsibilities:
Required Qualifications and Experience:
- Work in a team of QC Technicians
- Coordinate method transfer and qualification to CTOs and CMOs as needed
- Lead investigations at CMO/CTOs
- Manage contracts and budgets for CMO/CTO as needed
- Execute and Optimize QC test methods
- Organizing, reporting and trending test results
- Draft Quality documentation including: SOPs, test methods, protocols and reports
- Initiate and participate in laboratory and out of specifications (OOS) investigations
- Maintain the QC laboratory and associated equipment
- Maintain an up-to-date training file for the QC Department
- B.S. degree in biology or related field
- Minimum 8 years' experience working in a QC lab setting.
- Expertise with LC laboratory techniques.
- Have a strong knowledge of ISO 13485 and ISO 9001 Quality Management Standards and/or cGMP concepts
- 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
- Strong interpersonal skills and the ability to effectively collaborate with customers and internal and external colleagues
- Have a working knowledge of MS Office applications, SAP and ELN/LIMS systems
- Ability to travel to support CMO/CTO management, up to 20%
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 (see application details) or call (see application details) to let us know the nature of your request.