Quality Control Analyst II
Location: Piscataway, NJ
Hours / Schedule: Monday-Friday, 8:30AM-5:00PM (with occasional early / late hours once per month during production runs)
Type: Direct Hire
Compensation: $75,000 - $82,000 (based on experience)
Overview
Join a growing biopharmaceutical company that is expanding its Quality Control operations! This is a unique opportunity to advance your career in a collaborative, cutting-edge environment where you’ll work with both late-stage clinical and commercial small molecule and biosimilar products. Candidates with GMP, regulatory knowledge, protein chemistry and analytical troubleshooting sought this role.
- Level II: 6+ years (Bachelor’s) or 3-4 years (Master’s)
- Level III: 10+ years (Bachelor’s) or 8+ years (Master’s)
- Execute analytical testing for in-process, raw material, release, and stability samples
- Perform and troubleshoot methods including HPLC (Empower)
- Troubleshoot SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays (although some experience in this area is desired, training be provided).
- Document results in compliance with GMP, ICH, and FDA standards
- Author and revise SOPs, QC methods, technical reports, and investigation summaries
- Support batch release, batch record reviews, and regulatory dossier preparation
- Lead and/or support laboratory investigations, deviations, OOS results, and CAPAs
- Participate in Quality Events and regulatory inspections (e.g., PAI)
- Collaborate with cross-functional teams to ensure laboratory readiness and continuous improvement
- Bachelors Degree in biotechnology, Biochemistry, Chemistry or related field.
- Strong Quality Control experience in a pharmaceutical manufacturing environment.
- Previous cGMP laboratory experience - required
- 3 - 10 + years of experience with a major focus on QC work.
- Proficiency with HPLC and Empower required (must be on resume)
- SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays a plus (training will be provided – must be willing to learn and execute these tests- an opportunity to gain experience and expand your skill set).
- Expertise in small molecules and protein chemistry
- Ability to troubleshoot analytical data and interpret/report results accurately
- Experience supporting regulatory inspections and preparing data packages/dossiers strongly desired
- Strong technical writing & documentation skills (SOPs, QC methods, reports)
This position is a direct hire position with benefits.
Keywords: HPLC, UPLC, Empower, SDS-PAGE, CE-SDS, capillary electrophoresis, ELISA, cell-based bioassay, potency, protein chemistry, biologics QC, biosimilars, cGMP, GMP, OOS, OOT, deviations, CAPA, stability testing, raw material testing, in-process testing, batch release, data integrity, SOP writing, regulatory dossier, CMC, PAI, FDA inspection, SVP, subvisible particles, USP <1788> , LIMS, QMS #M3-
#LI-
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Ref: #558-Scientific Ref: #558-Scientific
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