Jt017 - Specialist QA

• Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
• Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
• Approve process validation protocols and reports, including PPQs and cleaning validation documentation
• Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
• Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
• Approve Environmental Characterization and environmental monitoring reports
• Release and maintain compliance of sanitary utility systems
• Represent Quality Assurance on New Product Introduction (NPI) teams
• Lead and document investigations, root cause analyses, and CAPA development
• Lead and support site audits, including internal, external, and regulatory inspections
• Own, maintain, and continuously improve site quality program procedures
• Serve as QA Manager designee on the local Change Control Review Board (CCRB)
• Review and approve risk assessments and mitigation strategies
• Support automation systems, including review of validation and change documentation
• Support facilities, utilities, and environmental compliance programs
• Review and approve work orders, ensuring GMP and quality alignment
• Review, assess, and approve EMS/BMS alarms and associated quality documentation
• Review and approve NC investigations, CAPAs, and effectiveness checks
• Review, approve, and manage change controls across manufacturing, laboratory, and support systems
• Perform lot disposition and authorize product release for shipment

• Bachelor’s degree in related area
• 4+ years of directly related QA experience in a regulated manufacturing environment
• Experience in NPI, Change Control, Documentation Review, Validation, PPQ and FAT
• Strong knowledge and hands-on experience with Aseptic manufacturing processes
• Change Control Experience
• Proven experience with NPI, Change Control, FATs, Validation, PPQs, and Cleaning Validation
• Manufacturing and laboratory experience required
• Demonstrated expertise in GMP documentation practices, including protocol/report review, investigations, and regulatory submissions
• Strong understanding of manufacturing, distribution, QA/QC/QAL, validation, and process development activities
• 8hrs Monday to Friday (Administrative), available nonstandard as needed.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.