GMP Manufacturing Quality Specialist

• Provide Quality Assurance support for manufacturing operations, including shop floor presence and oversight.
• Perform batch record review, batch disposition, and support product release activities.
• Conduct Gemba walks, logbook audits, and quality oversight to ensure GMP compliance.
• Support warehouse and incoming quality processes, ensuring materials meet established specifications.
• Review and approve deviations, CAPAs, change controls, and quality documentation within electronic quality systems.
• Lead and support investigations related to deviations, non-conformances, and laboratory exceptions.
• Monitor quality metrics and trends to identify risks and drive continuous improvement initiatives.
• Ensure data integrity compliance, including ALCOA+ principles and 21 CFR Part 11 requirements.
• Participate in regulatory inspections and support inspection readiness activities.
• Collaborate cross-functionally to promote a culture of quality, compliance, and operational excellence.

• Bachelor's degree in a scientific or technical discipline with 2+ years of relevant biopharmaceutical manufacturing experience; OR
• Associate degree with 3+ years of relevant experience; OR
• High school diploma/GED with 4+ years of relevant experience.
• Experience in biologics, biotechnology, or pharmaceutical manufacturing environments preferred.
• Start-up, technology transfer, or facility commissioning experience is a plus.

• 2+ years in a GMP-regulated manufacturing environment.
• Hands-on experience with:
  • Batch record review and approval
  • Manufacturing/Shop Floor QA
  • Batch disposition and product release
  • Deviation, CAPA, and change control management
  • Quality investigations and root cause analysis
  • Regulatory inspection support
  • Electronic Quality Management Systems (eQMS), such as Veeva or similar platforms

• Working knowledge of cGMP regulations and quality systems.
• Experience with electronic document management and quality management systems.
• Proficiency with Microsoft Office applications.

• Ability to spend extended periods on the manufacturing floor (up to 3+ hours at a time).
• Ability to work a 12-hour rotating 2-2-3 schedule once manufacturing operations are fully operational.

Opportunity Awaits.