Specialist QA

Responsibilities

• Review and approve product Master Plans, process validation protocols, and environmental characterization reports
• Approve nonconformance investigations, CAPA records, and change controls to ensure quality system compliance
• Provide lot disposition and authorize lots for shipment
• Serve as the QA representative on New Product Introduction (NPI) teams and the local Change Control Review Board (CCRB)
• Lead site investigations, internal audits, and support external audit readiness
• Support automation, facilities, and environmental monitoring programs
• Collaborate with cross-functional teams to resolve quality or operational issues

Requirements

• Doctorate OR Master's + 2 years experience OR Bachelor's + 4 years experience OR Associate + 8 years experience OR HS/GED + 10 years experience
• Strong knowledge of manufacturing, distribution, QA, validation, and process development
• Experience interacting with regulatory agencies
• Advanced data trending, evaluation, and analytical skills
• Strong project management, organizational, and communication skills

Preferred Qualifications

• Experience performing batch record (EBR) review, approval, and reconciliation
• Experience providing QA oversight of manufacturing operations
• Experience managing events, investigations, and quality decision-making

Benefits

• 6-month contract
• 12-hour night shift (5:00 PM - 5:30 AM)
• Rotating coverage including weekends and holidays

About the Company

BioPharma Consulting JAD Group provides specialized expertise to support high-level quality assurance and regulatory compliance within the biopharmaceutical industry.