Quality Control Analyst II

Job Title:

Quality Control Analyst II/III (Biologics / Biosimilars)

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) Responsibilities + 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 Requirements + 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) Benefits This position is a direct hire position with benefits.  #M3- #LI- #DI- : #558-Scientific : #558-Scientific System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD.,

are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.