Quality Assurance Specialist

2 weeks ago


Piscataway, New Jersey, United States Joulé Full time
Job Summary: We are seeking a highly skilled Quality Control Analyst II to join our team at Joulé in a cGMP-compliant environment. The ideal candidate will have a strong background in small molecule and protein chemistry, analytical testing, and data verification to support late-stage clinical and commercial products.

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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