Principal Quality Assurance Specialist

Senior Quality Assurance Compliance Specialist (GMP Compliance)

Day Shift | $85,000–$95,000 base + bonus | Excellent benefits

Our client is a global pharmaceutical manufacturer supporting life-saving critical care products. Due to continued growth, they are hiring a Senior Quality Assurance Compliance Specialist to support GMP operations, documentation, and quality systems in a regulated manufacturing environment.

Key Responsibilities:

• Review and disposition finished product and provide final CoA approval/signature
• Lead and support deviation investigations, CAPAs, and change controls
• Ensure timely closure of non-conformances with strong root cause analysis
• Review and approve laboratory investigations
• Support regulatory inspections and internal/external audits
• Perform internal audits and assist with audit report writing
• Support and maintain document control systems (eDMS), including document routing and archival
• Review/approve SOPs, BOMs, inspection plans, calibration records, and quality documentation
• Support APR activities, trend reporting, and quality metrics
• Maintain vendor complaint process and supplier approval program
• Provide training support and guidance to QA team members
• Occasional travel up to 25%

Qualifications:

• 7+ years Quality Assurance experience in a GMP pharmaceutical manufacturing environment
• Strong experience with deviations, CAPA, change control, and batch record review
• Working knowledge of document control/eDMS systems
• Experience supporting regulatory inspections and audits
• Strong attention to detail, communication skills, and ability to work cross-functionally.