On-Site QA Specialist — GMP & Continuous Improvement

American Society for Quality; Zebulon (NC); On-site; USD 75,000 - 105,000; Full time

Job summary

American Society for Quality seeks a QA Specialist to join our Zebulon, NC facility, supporting GMP-compliant QA review for Investigational Medicinal Products distributed worldwide.

This is a full-time, on-site role (first shift 8:00 am to 5:00 pm). You will serve as Batch Release Officer, review GMP docs, and contribute to QMS improvements across Clinical Supply Chain packaging and logistics.

Qualifications

• Bachelor's degree or equivalent experience (5+ years in a similar role).
• QA review experience with GMP documentation and/or lab records for pharmaceutical dosage forms.
• Strong knowledge of GMP principles and decision-making based on GMP.
• Experience leading or participating in QMS activities (deviations, complaints, change controls, audits).
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Responsibilities

• Serve as Batch Release Officer reviewing and recommending documentation release for dosage form batches.
• Assess Quality QMS records and propose corrective actions.
• Review and approve GMP documentation from Clinical Supply Chain packaging and logistics.
• Provide quality-related advice to business partner areas.
• Contribute to development of processes within Quality R&D Supply QA/QP US.
• Participate in audits/regulatory inspections and high-priority projects.
• Lead or contribute to continuous improvement initiatives.

Skills

GMP knowledge

QMS experience

MS Office

Decision making

Education

Bachelor's degree or equivalent in related field

5+ years in similar role

Tools

GMP documentation review tools

Job description

American Society for Quality seeks a QA Specialist to join our Zebulon, NC facility, supporting GMP-compliant QA review for Investigational Medicinal Products distributed worldwide.

This is a full-time, on-site role (first shift 8:00 am to 5:00 pm). You will serve as Batch Release Officer, review GMP docs, and contribute to QMS improvements across Clinical Supply Chain packaging and logistics.