Quality Control Analyst II

Job Title: Quality Control Analyst II
Location: Piscataway, NJ
Type: Direct Hire
Compensation: $75,000 - $82,000
Contractor Work Model: Onsite – onsite
Hours: 8:30AM-5:00PM Monday-Friday (with occasional early/late hours during production runs)

Responsibilities

• Perform analytical testing supporting in-process, raw material, release, and stability samples in a cGMP laboratory environment.
• Execute and troubleshoot analytical methods such as HPLC (Empower), SDS-PAGE, bioassays, capillary electrophoresis, and ELISA.
• Document results in compliance with GMP, ICH, and FDA standards, including authoring and revising SOPs, QC methods, and technical reports.
• Support batch release, review batch records, and prepare data for regulatory dossiers.
• Lead or assist in laboratory investigations, deviations, OOS results, and CAPAs, ensuring timely resolution and compliance.
• Participate in quality events and regulatory inspections, including PAI, contributing to audit readiness.
• Collaborate with cross-functional teams to improve laboratory processes and ensure continuous compliance.
• Maintain equipment, support investigations during non-conformance, and prepare investigation reports.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with 3-4 years of experience in a pharmaceutical/biotech QC laboratory.
• Strong experience supporting cGMP laboratory operations in the pharmaceutical or biotech industry.
• Proficiency with HPLC and Empower software is required.
• Experience with SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and standard compendial assays (training provided).
• Knowledge of small molecule and protein chemistry and troubleshooting analytical data.
• Experience supporting regulatory inspections and preparing data packages/dossiers.
• Strong technical writing skills, including SOPs, QC methods, and reports.
• Ability to work under pressure in a high-paced environment and lift at least 25 lbs.
• Willingness to work extended hours and occasional weekends during production runs.
• Excellent collaboration skills for cross-functional teamwork and process improvements.

System One, and its subsidiaries including Joulé 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.
#M-
#LI-ES2

Ref: #558-Scientific