Quality Assurance Associate, Solution Lot Records (Contractor)
Location: Durham, NC (On-Site)
Schedule: Monday - Friday, 8am - 5pm
Contract Terms: 6 months with potential for extension and opportunity to apply for full-time positions after 5 months
Max Pay Rate: $30.00/hr
About the Role:
A company is seeking a detail-oriented and highly organized Quality Assurance Associate to join their team at the Research Triangle Park (RTP) facility. This is a critical, on-site role focused on ensuring cGMP compliance within Quality Assurance and manufacturing operations. You will play a key part in the oversight of batch-related documentation and the day-to-day implementation of the Quality Management Systems.
What You'll Do:
- Review and approve batch-related documentation, including Solution Lot records, reports, and logbooks, to support product disposition.
- Perform physical visual inspections and GDP (Good Documentation Practices) inspections of autoclaved equipment.
- Transport batch-related documentation across RTP buildings to support chain of custody and life cycle management.
- Support the resolution of technical and compliance issues of mild to moderate complexity.
- Meet with responsible personnel on the manufacturing floor to correct documentation discrepancies or errors.
- Assist in the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy, and purity of the products manufactured.
Required Skills and Experience:
- 0-2 years of directly related experience or a background in a biologic setting is preferred.
- Familiarity with systems such as Oracle, Trackwise, Syncade, and Kneat is preferred.
- Strong attention to detail with the ability to perform accurate visual and documentation inspections.
- Excellent communication skills to interface with manufacturing personnel and resolve compliance issues.
- Ability to work in a manner consistent with site and corporate policies, cGMP, and safety regulations