Quality Assurance Specialist
1 day ago
Sapta Global Inc is seeking a highly skilled Senior Quality Assurance Specialist to join our team in New Brunswick, NJ.
Job Summary:This is an 18 to 24 month opportunity to gain experience with Bulk Drug Substance manufacturing. As a Senior Quality Assurance Specialist, you will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support.
Responsibilities:- Provides oversight for CMO Batch Production Records. Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.
- Assists with Document Control and other QA functions.
- Coordinates and assist in timely review of documentation associated with manufacturing at CMO site.
- Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and follows the completion of CAPAs from audit findings.
- Gives guidance to CMO as needed and ensure CMO is compliant with Client Quality standards.
- Ensures that all audit items are resolved. Supports site for Inspection.
- BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
- Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Must be fluent in English language.
- Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
Sapta Global Inc offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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