Quality Assurance Specialist
2 weeks ago
Responsibilities:
- Perform analytical testing and data verification for 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 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).
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:
- Joulé offers eligible employees comprehensive 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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