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Quality Assurance Lead

4 weeks ago


Piscataway, New Jersey, United States Joulé Full time
Job Title: Quality Assurance Lead

Joulé is seeking a seasoned Quality Assurance Lead to oversee Quality Control operations and ensure compliance with cGMP requirements.

About the Role:
  • The successful candidate will support Quality Control leadership, schedule QC analysts weekly plans, and conduct analytical testing activities on time.
  • They will demonstrate chain of custody of samples, plan for testing, and result reporting in a timely manner.
  • This role involves authoring, reviewing, and revising technical documents, as well as working with CMC and regulatory teams for IND/BLA/MAA filings.
Requirements:
  • Bachelor's Degree in chemistry/Molecular Biology or Cell Biology with 12+ years of experience.
  • M.S. in Chemistry/Biology, Molecular biology, with 8+ years of industry experience or relevant experience in QC or equivalent experience in Pharmaceutical/Biopharmaceutical industry.
  • cGMP knowledge and experience in Pharmaceutical/Biopharmaceutical industry are essential.
  • Excellent problem-solving skills, including statistical analysis, and ability to use these tools to drive root cause identification and problem solving.
Benefits:
  • $120,000 - $150,000 per annum, depending on experience.
  • A comprehensive benefits package, including health insurance, retirement savings, and paid time off.
  • Opportunities for professional growth and development.