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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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, age (40 or older), veteran status, disability and genetic information (including family medical history).