Quality Associate III

Duration: 12+ Months (40hrs/weeks)

The QA Associate III in the Quality Systems organization is responsible for understanding quality systems, contributing to oversight of quality systems, and maintaining GMP activities at the Client RTP Bio facility. They should be proficient in their understanding of quality systems and apply that knowledge in execution of assigned tasks and continuous improvement.

The primary responsibilities of the QA Associate III in the Quality Systems team include, but are not limited to, the timely and accurate issuance of GMP documents and records (SOPs, BPRs, SLRs, Labels, and Logbooks) required to support internal site production operations for the RTP Bio site. In addition, they will perform review of executed GMP documents (Standard Operating Procedures, Labels, and Logbooks) for compliance to applicable regulatory and corporate guidance documents and identify and assess discrepancies with business source documentation. The QA Associate III will serve as quality oversight on assigned deviations, CAPAs and change controls to ensure compliance with regulatory, business and process requirements/guidelines. They will generate, analyze, and communicate Site Quality Systems Metric Reports (Quality Systems Metric reporting and Site Management Review Report).

Additional responsibilities of the QA Associate III include supporting implementation of identified Quality System improvements as part of a team, as well as support of regulatory inspections and all other job duties as assigned by management.

Accountability Description

1. Issuance of Batch Production Records, Solution Lot Records, Labels, and Logbooks.
2. Review and approve site-specific GMP documents and records.
3. Serve as quality oversight on assigned deviations, CAPAs and change controls
4. Generate, analyze, and communicate Site Quality Systems Metric Reports
5. Support implementation of Quality System improvements.
6. Prepare for and support site inspections and audits.

And other job duties that may be assigned from time to time.

The position requires but is not limited to the following:

• Demonstrated leadership abilities.
• Proficient understanding of internal quality systems and requirements
• Strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively.
• Strong organizational skills: ability to prioritize and coordinate multiple activities in parallel.
• Demonstrated troubleshooting and problem-solving skills.
• Knowledge of FDA/EMEA regulations and compliance.

Minimum Bachelor of Science in a scientific/technical discipline. 4-6 years appropriate industry experience in a regulated environment.

Shift: M-F 1st Shift