We are seeking a QA Associates to support quality operations within a regulated pharmaceutical manufacturing environment. These roles are responsible for ensuring GMP compliance through batch record review, quality documentation oversight, manufacturing support, and quality systems activities.
QA professionals with 3+ years GMP operations experience are encouraged apply!
Location: Durham, NC
Pay: $30-$40/hour depending on experience
Schedule: M-F 9:00 AM-5:00 PM
Responsibilities
- Review batch production records, logbooks, and inspection documentation for accuracy, completeness, and GMP compliance.
- Ensure documentation follows Good Documentation Practices and data integrity requirements.
- Support quality review and approval processes for manufacturing activities.
- Assist with quality investigations, deviations, CAPAs, and documentation updates as needed.
- Partner with manufacturing personnel to resolve documentation issues and support compliance initiatives.
- Maintain quality records, tracking logs, and regulatory documentation.
- Participate in routine manufacturing floor activities to provide QA support and oversight.
Qualifications
- Bachelor's degree in Life Sciences, Biology, Chemistry, or a related scientific discipline required.
- Minimum of 3 years of Quality Assurance experience in a biotechnology, biopharmaceutical, or pharmaceutical manufacturing environment.
- Experience supporting biologics, gene therapy, cell culture, purification, aseptic processing, or other GMP operations.
- Experience reviewing batch records and GMP manufacturing documentation.
***This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!***
Quality Assurance Specialist in Durham at Astrix
This position is listed as full time and onsite. It was posted 3 days ago.