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.
- 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%
- 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
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Masis Staffing is committed to providing a workplace free of discrimination, harassment, and retaliation. We are an equal opportunity employer. Applicants, employees, and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation or transgender status), national origin, aids (40 or older), veteran status, disability and genetic information (including family medical history).
