The QA Engineer is responsible for providing Quality Assurance oversight of Engineering and Facilities activities, with a primary focus on reviewing and approving qualification and validation documentation, including IQ/OQ/PQ protocols and reports, commissioning records, Computer System Validation (CSV) packages, and related GMP documentation.

This role ensures engineering systems, utilities, equipment qualification activities, and facility operations are conducted in compliance with cGMP, FDA, EMA, and ICH requirements, with a strong emphasis on data integrity (ALCOA+), documentation practices, and risk-based decision making. The position also supports vendor quality management, internal audits, and continuous improvement initiatives. This role reports to the QA Manager, Analytical.

Essential Duties and Responsibilities

Engineering & Facilities Quality Assurance

• Review and approve engineering documentation, SOPs, protocols, records, and GMP documentation related to Engineering, EHS, and Facilities activities.
• Review and approve equipment qualification, calibration, validation, and CSV documentation.
• Review facility and utility documentation, including HVAC and water systems, ensuring systems remain qualified and maintained in a validated state.
• Review maintenance, pest control, and facility records for compliance with site procedures and regulatory requirements.
• Review environmental monitoring data, initiate Quality Events (QEs) as needed, and perform trend analysis.
• Review deviations, investigations, incidents, and CAPAs related to facilities, equipment, and engineering activities.
• Monitor quality metrics and documentation to support internal reporting and Annual Product Reviews (APRs).

Vendor Quality Management

• Support vendor qualification, requalification, audits, and risk assessments.
• Review vendor change notifications and assess potential quality impact.
• Collaborate with cross-functional teams to resolve supplier quality issues.
• Monitor vendor performance metrics and KPIs.

Internal Audit & Compliance Support

• Support quality systems including deviations, CAPAs, change control, document control, and inspection readiness.
• Participate in internal audits and support regulatory inspections and customer audits.
• Assist with corrective and preventive action implementation.
• Drive continuous improvement initiatives to strengthen quality systems and compliance.