Quality Assurance Associate

5 days ago

Durham NC, United States Randstad USA Full time

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: We are seeking a detail-oriented and highly organized Quality Assurance Associate to join our 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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