What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Masis Professional Group?
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.
Salary : $85,000 - $95,000