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.