QA Specialist

The QA Specialist/Manager supports in activities for Biologics and Branded medicinal products by ensuring operational GMP compliance, coordinating oversight of external manufacturers, maintaining MAH‐required documentation, and facilitating communication between internal teams, manufacturing sites, and regulatory authorities.

Requirements

• GMP/GDP & MAH Compliance
• Oversight of Outsourced Activities
• Audit & Qualification Support
• Unplanned deviations, Complaints & Recalls
• Change Control Support
• Collaboration with cross departments
• Technical skills/job specific competencies
• Behavioral Skills/Competencies

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement
• Relocation Assistance