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
- Pay $30 - $33/hour
- 2-2-3 schedule – 12 hour rotating shift
- 1 year + contract duration
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.
Required 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.
- 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
Technical Skills
- Working knowledge of cGMP regulations and quality systems.
- Experience with electronic document management and quality management systems.
- Proficiency with Microsoft Office applications.
Additional Requirements
- 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.
If you meet the required qualifications and are interested in this role, please apply today.
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About Solomon Page
Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit:
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