QA Documentation Specialist III

Job Description:

The QA Engineer is responsible for ensuring timely development, review, and approval of engineering, validation, and lifecycle documentation in alignment with corporate procedures, SOPs, cGMP, and industry best practices. This role supports manufacturing, engineering, validation, and quality teams by providing oversight across the full validation lifecycle, ensuring inspection readiness, and maintaining a compliant state for all equipment, utilities, systems, and processes. The QA Engineer plays a key role in supporting new installations, change controls, deviations, CAPAs, and continuous improvement initiatives.

Responsibilities:

• Quality Review & Documentation Oversight:


• Review and approve engineering and validation documentation including IQ, OQ, PQ, PPQ, Validation Master Plans, risk assessments, calibration records, and periodic reviews.


• Create, review, an...