Quality Assurance (QA) Engineer / Senior QA Specialist (TEST)
Experience Required: 7โ10 Years
Location: Raleigh, NC
Visa: US Citizen / Green Card
Mode of Work: In-office
Duration: 10 to 12 months +
Role Overview
The QA Engineer / Senior QA Specialist will provide experienced, hands-on quality oversight for commercial GMP manufacturing operations. This role requires strong judgment, deep knowledge of GMP regulations, and the ability to independently manage quality events while partnering closely with Manufacturing, Validation, and Engineering teams in a regulated environment.
Key Responsibilities
* Provide independent QA oversight for commercial GMP manufacturing operations in compliance with 21 CFR Parts 210/211, EU GMP, and ICH Q10.
* Own and manage deviations, CAPAs, and change controls in TrackWise, including leading investigations, performing root cause analysis, assessing product impact, and ensuring timely, effective closure.
* Review and approve validation and qualification documentation (including IQ/OQ/PQ, protocols, reports, and summary documentation) using Kneat, ensuring compliance with GMP, data integrity, and regulatory expectations.
* Perform thorough batch record review and release support, identifying trends, risks, and opportunities for process improvement.
* Support equipment lifecycle activities, including maintenance, calibration, and qualification, through review of GMP documentation and records in CMMS.
* Review, approve, and maintain controlled documents, SOPs, and training records in Veeva Vault, ensuring accuracy, compliance, and inspection readiness.
* Contribute to the development, revision, and continuous improvement of QA procedures, processes, and documentation to support operational readiness and manufacturing excellence in a cGMP facility.
* Serve as a QA point of contact for manufacturing operations, providing guidance on GMP expectations, deviation handling, and change implementation.
* Support regulatory inspections, internal audits, and customer audits, including preparation, participation, and follow-up actions.
* Mentor junior QA team members and provide guidance on GMP best practices, as needed.
Systems & Tools
* TrackWise โ Deviations, CAPAs, Change Control
* Kneat โ Validation, Qualification, Batch Record Review
* Veeva Vault โ Document and Training Management
* CMMS โ Equipment Maintenance and Calibration Records
Qualifications
* Bachelorโs degree in Science, Engineering, or a related discipline (or equivalent experience).
* 7โ10 years of Quality Assurance experience in a cGMP-regulated environment (pharmaceutical, biotech, or related industry).
* Strong working knowledge of FDA, EU, and ICH GMP regulations.
* Proven experience independently managing quality investigations, change controls, and validation documentation.
* Experience supporting commercial manufacturing operations.
* Strong communication, documentation, and cross-functional collaboration skills.
* Demonstrated ability to work independently while balancing multiple priorities in a fast-paced GMP environment