Documentation Specialist

Job Title: Quality Assurance Associate II

Location: RTP City, NC

Duration: 12 Months

Job Description:

The Quality Assurance Associate II (Contractor) is responsible for contributing to the oversight of key strategic, and operational aspects within Quality Assurance at the Client Research Triangle Park (RTP) facility. Activities include but are not limited to a review of GMP raw data for compliance. The QA Associate II will perform all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental, and human resources policies and procedures and adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers.

Review and approval of batch related documentation (Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment) to support product disposition.

• Transport batch related documentation across RTP buildings to support chain of custody and life cycle management.

• Supports resolution of both technical and compliance issues/gaps of mild to moderate complexity.

• Assists Quality Assurance Management in additional responsibilities related to 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 by Client.

• Complete and maintain related GMP training.

• Additional job duties that may be assigned from time to time.

• 0-2 years directly related to position responsibilities or biologic experience preferred.