System One Holdings, LLC

Compensation

Full Description

Job Title: Quality Control Analyst II/III Location: Piscataway, NJ (Onsite: some travel to South Plainfield) 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 must bring strong GMP and regulatory knowledge, with expertise in protein chemistry and analytical troubleshooting. If you enjoy problem-solving, hands-on testing, and contributing to life-changing therapies, this role is for you. Responsibilities: • Execute analytical testing for in-process, raw material, release, and stability samples • Perform and troubleshoot methods including HPLC (Empower), SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays • 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 Requirements: • Bachelor's in Biotechnology, Biochemistry, Chemistry, or related field with 3-10+ years QC experience, depending on level: • Level II: 6+ years (Bachelor's) or 3-4 years (Master's) • Level III: 10+ years (Bachelor's) or 8+ years (Master's) • Previous cGMP laboratory experience - required • Strong Quality Control experience in a manufacturing environment • Demonstrated expertise in small molecules and protein chemistry • Proficiency with HPLC (Empower), SDS-PAGE, ELISA, bioassays, and compendial assays • Ability to troubleshoot analytical data and interpret/report results accurately • Prior experience supporting regulatory inspections and preparing data packages/dossiers • Strong technical writing & documentation skills (SOPs, QC methods, reports) Ref: #558-Scientific