Quality Control Analyst II / III - Biologics

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)

Benefits
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.


#M3


Ref: #558-Scientific