Bulk Drug Substance Manufacturing Lead

3 days ago


Signal Hill, California, United States Sapta Global Inc Full time
Job OpportunityAbout the JobWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Sapta Global Inc. The ideal candidate will have extensive knowledge of GMP regulations and quality systems.

This role is responsible for providing quality oversight to the Contract Manufacturing Organization (CMO) and ensuring compliance with client quality standards.

Key Responsibilities:
  • Manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release.
  • Coordinate and assist in timely review of documentation associated with manufacturing at CMO site.
  • Escalate critical quality problems to Senior Management in a timely manner.
Qualifications:
  • Bachelor's degree in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
  • Excellent communication and leadership skills.
Additional Information:

This is a contract position with a duration of 18-24 months.

The salary for this position is $25 per hour.



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