Quality Control Analyst II

Job Title: QC Analyst II
Location: Piscataway, NJ
Hours/Schedule: M-F, 8:30 am – 5:00 pm (May require extended hours or weekends during manufacturing runs)
Type: Temporary to Hire

Overview
We are seeking a QC Analyst II with a strong background in small molecule and protein chemistry to support our client’s QC laboratory in a cGMP-compliant environment. The role involves analytical testing and data verification to support both late-stage clinical and commercial products, including biosimilars. The ideal candidate will be skilled in troubleshooting analytical results and working with cross-functional teams on projects, process improvements, and laboratory investigations.

Responsibilities

• Perform analytical testing and data verification to support in-process, release, raw materials, and stability programs.
• Conduct testing using HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, and ELISA.
• Collaborate across departments to resolve project issues, conduct lab investigations, and implement process improvements.
• Document and investigate Out of Specification results, deviations, and implement corrective actions.
• Support regulatory inspections and prepare dossiers for agency interactions.
• Maintain laboratory equipment and comply with all company policies, standards, and regulatory guidance.

Requirements

• Education:

  • Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 8 years of QC experience in pharma/biotech.
  • OR Master’s degree in the above fields with 6 years of QC experience in pharma/biotech.

• Experience and Skills:

  • Prior experience in a cGMP laboratory is essential.
  • Strong knowledge in protein and small molecule chemistry and proficiency with techniques such as HPLC, SDS-PAGE, ELISA, and capillary electrophoresis.
  • Experience with SOPs, QC methods, and regulatory dossiers.
  • Demonstrated ability to support regulatory inspections (e.g., PAI).

Working Environment

• Primarily lab-based with some office work for documentation.
• Must be able to lift 25 lbs.
• Travel up to 5%-10% as needed.

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.