Job Title: Quality Control Analyst II/III Location: Piscataway, NJ Type: Direct Hire Work Model: Onsite Hours: Monday–Friday, 8:30 AM – 5:00 PM (may start earlier or stay later once a month during manufacturing runs) Salary: Competitive and depending upon experience Travel: 5%–10% (80% Piscataway, 20% South Plainfield) Interview Process: Onsite with Director, team peers, and HR Overview: Our client is expanding their QC operations, great opportunity to work with an outstanding company. Education & Experience Requirements: • Level I: Bachelor’s in biotechnology, biochemistry, chemistry, or related field with 3–4 years of QC experience in a pharma/biotech environment. • Level II: o Bachelor’s + 6+ years of experience, OR o Master’s + 3–4 years of experience • Level III: o Bachelor’s + 10+ years of experience, OR o Master’s + 8 years of experience Must-Haves: + cGMP laboratory experience + Strong QC experience in a manufacturing environment + Solid background in small molecule and protein chemistry + Skilled in HPLC (Empower), SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and compendial assays + Experience troubleshooting analytical results + Familiarity with regulatory dossiers and supporting inspections (e.g., PAI) + Strong documentation skills: writing/revising SOPs and QC methods + Ability to process, interpret, and report analytical data Key Responsibilities: + Perform analytical testing for in-process, release, raw material, and stability samples + Support both late-stage clinical and commercial small molecule and biosimilar products + Investigate non-conformances and contribute to Quality Events + Author technical documents, reports, and investigation summaries + Support regulatory inspections and ensure compliance with ICH and GMP standards + Collaborate with cross-functional teams to maintain equipment and improve lab processes Work Environment: + Office and laboratory setting + Must be open to extended or weekend hours, as needed + Fast-paced and deadline-driven environment Organizational Info: + Business Unit: Quality Management + Department: Quality Control + Reports to: QC Director Keywords: SVPs, USP 1788, Bioassay, Mammalian, ELISA, HPLC, Empower, Regulatory Dossiers, Regulatory Inspections, PAI, SOP Writing #M #LI- #DI- Ref: #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.