We are seeking both Junior and Senior 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.
Are you the right candidate for this opportunity Make sure to read the full description below.
Whether you are an early-career QA professional or a seasoned QA Operations specialist, we encourage candidates with hands-on GMP Quality Assurance experience and exposure to biologics or advanced bioprocessing operations to apply!
Location: Durham, NC
Pay: $30-$60/hour depending on experience
Schedule: M-F 9:00 AM-5:00 PM with occasional schedule flexibility
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 bioprocessing 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. xhqgsiq 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 Unknown Company
This position is listed as full time and onsite.