Job Description

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

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