Description
This position is with an exciting Biotech company in the Bay Area. They have several drugs on the market and are actively seeking a QA Operations Manager. This individual will support the manufacture of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) to ensure compliance with Good Manufacturing Practices (GMP). The position involves review of master batch records and executed batch records to ensure appropriate quality for product release for their intended use.Key Responsibilities:
- Quality oversight of contract manufacturing organizations.
- Quality representative for FDA investigations related to product compliance. Includes oversight and evaluation of discrepancies and CAPAs.
- Master Batch Record (MBR) review and approval as compliant with good manufacturing practice regulations, regulatory filings and quality agreements.
- Manages all documents received from CMOs through document change control and archival process, as required by internal procedures.
- Review of executed batch records, Certificates of Analysis, QC data and other documents to enable drug substance and drug product release certifying batches as GMP compliant.
- Coordinate annual product quality reviews with suppliers and internally as required.
- Initiate updates and creation of new SOPs as required.
Skills Required:
- 5+ years working in Quality Assurance for an FDA regulated Pharmaceutical or Biotech company.
- Highly extensive knowledge of cGMP standards and quality systems.
- Must posses Quality management and leadership skills.
- 20-30% travel required
If you believe that you have the skills and can fulfill these responsibilities, please apply and I will reach out to you shortly.
To find out more about Real please visit www.realstaffing.com