Careers at Masis Staffing Solutions

Principal Quality Assurance Compliance Specialist
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 Principal 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:

• Minimum of 10 years of Quality Assurance experience in a GMP pharmaceutical manufacturing environment (required)
• Bachelor’s degree preferred.
• Experience writing and/or approving deviations
• Experience implementing robust CAPAs
• Strong RCA (root cause analysis) skills
• Expertise in regulatory requirements
• QA batch record review experience
• Experience creating/writing SOPs and work instructions
• Experience with quality metrics and trending
• QC/Laboratory background helpful but not required

Systems/Applications:
TrackWise, SAP, Ensur, PasX, Adobe, MS Office

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