Quality Control Analyst II

Joul - Piscataway, NJ

Full-time - Mid Level

Piscataway, NJ

About the position

The QC Analyst II position is designed for individuals with a strong background in small molecule and protein chemistry, aimed at supporting a QC laboratory in a cGMP-compliant environment. This role focuses on analytical testing and data verification for late-stage clinical and commercial products, including biosimilars, while collaborating with cross-functional teams to enhance processes and resolve project issues.

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

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

Benefits

• Health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.