QA Engineer

About the Role

The QA Engineer provides 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.

Responsibilities

• 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).
• 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.
• 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.

Qualifications

• Bachelor’s degree (B.S.) in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or a related scientific discipline.
• Minimum of five (5) years of Quality Assurance experience in an FDA-regulated pharmaceutical and/or medical device manufacturing environment.
• At least three (3) years of direct QA experience supporting Engineering and Facilities functions, including:
  • Review and approval of IQ/OQ/PQ protocols and reports.
  • Equipment qualification and validation lifecycle activities.
  • Engineering documentation and GMP record review.
• Strong knowledge of cGMP regulations, ICH guidelines, FDA, EMA, and other applicable global regulatory requirements.
• Working knowledge of SOPs, qualification and validation principles, HVAC systems, water systems, ALCOA+ data integrity principles, and associated regulatory expectations.
• Proficiency in Microsoft Office applications and electronic Quality Management Systems (eQMS).
• Strong organizational, analytical, and problem-solving skills.
• Excellent verbal and written communication skills in English.

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility