Quality Assurance Specialist in Protein Chemistry
3 weeks ago
We are seeking a skilled Quality Assurance Specialist to support our client's QC laboratory in a cGMP-compliant environment. The ideal candidate will have a strong background in small molecule and protein chemistry, with experience in analytical testing and data verification.
About the Role:
This is a unique opportunity to work in a dynamic laboratory setting, supporting both late-stage clinical and commercial products, including biosimilars. As a Quality Assurance Specialist, you will be responsible for conducting analytical testing and data verification, collaborating across departments to resolve project issues, and implementing process improvements.
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:
To be successful in this role, you will need a Bachelor's degree in biotechnology, biochemistry, chemistry, or a related field, with a minimum of 8 years of QC experience in pharma/biotech. Alternatively, a Master's degree in one of these fields with 6 years of QC experience in pharma/biotech is also acceptable. Prior experience in a cGMP laboratory is essential, as well as strong knowledge in protein and small molecule chemistry and proficiency with techniques such as HPLC, SDS-PAGE, ELISA, and capillary electrophoresis.
Estimated Salary: $80,000 - $110,000 per year, depending on experience and qualifications.
Location: Piscataway, NJ.
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: We offer 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.
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