About this opportunity
Astek lists this QA Specialist opportunity in zebulon, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 US
Participate 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
Worksite address
zebulon, NC, 27597, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.