GMP Manufacturing Quality Specialist

About the role

Our client is looking to fill the role of GMP Manufacturing Quality Specialist. This position supports GMP-regulated quality assurance activities across manufacturing, warehouse, and incoming materials operations, ensuring compliance with global quality standards, regulatory requirements, and internal procedures. The role offers the opportunity to contribute to facility readiness, technology transfer, inspection preparedness, and commercial manufacturing success. Onsite in Sanford, NC. Contract duration: 1 year +.

Responsibilities

• 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.

Qualifications

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. Required Experience: 2+ years in a GMP-regulated manufacturing environment.

Skills

• 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.

Benefits

• Medical
• Dental
• 401(k)
• Direct deposit
• Commuter benefits

Pay

$30 - $33/hour

Schedule

2-2-3 schedule – 12 hour rotating shift