QA Specialist
astekRaleigh (NC)
About the role
QA Specialist - Zebulon, NC (On-site) We are hiring a QA Specialist to join a global pharmaceutical organization at its Zebulon, NC facility, supporting the quality and compliance of Investigational Medicinal Products distributed worldwide. This is a full-time, on-site position (first shift, 8:00 am to 5:00 pm).
Key Responsibilities:
- Serve as Batch Release Officer, reviewing and recommending release of documentation for dosage form batches and finished clinical trial packs, in line with GMP requirements
- Assess Quality QMS records (deviations, internal and third-party complaints) and recommend corrective and preventive actions
- Review and approve GMP documentation (SOPs, Change Controls, and other controlled documents) from business partner areas such as Clinical Supply Chain packaging and logistics
- Provide quality-related advice and support to business partner areas
- Contribute to the development of processes and procedures within Quality R&D Supply QA/QP USParticipate in audits/assessments, regulatory inspections, and high-priority projects
- Lead or contribute to continuous improvement initiatives
Required:
- Bachelor's degree or equivalent experience (5+ years in a similar role)QA review experience with GMP manufacturing/packaging documentation and/or laboratory records for pharmaceutical dosage forms (sterile products a plus)
- Solid working knowledge of GMP principles, with proven decision-making based on this knowledge
- Experience leading or participating in QMS activities (deviations, complaints, change controls, inspections/audits, root cause analysis)
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Preferred:
- Experience working in high-pressure environments with competing priorities
- Knowledge of R&D processes, particularly clinical trials manufacturing and packaging
- Strong attention to detail
- Excellent communication skills and ability to build trust-based relationships
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