QA Specialist at Astek QA Specialist at Astek in Zebulon, North Carolina Posted in 1 day ago.

Type:

full-time 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