QA Specialist

American Society for Quality; Zebulon, Northern (NC, KY); Hybrid; USD 80,000 - 110,000; Full time

Job summary

American Society for Quality is seeking a QA Specialist to join the Zebulon, NC facility, supporting GMP-compliant quality and regulatory oversight of Investigational Medicinal Products distributed worldwide. This is a full-time, on-site role (first shift, 8:00 am to 5:00 pm).

The candidate will review batch documentation, participate in audits, and drive QMS improvements across Clinical Supply Chain packaging and logistics.

Qualifications

• Bachelor's degree or equivalent experience.
• QA review experience with GMP manufacturing/packaging documentation and/or laboratory records.
• Solid working knowledge of GMP principles.
• Experience leading or participating in QMS activities.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Responsibilities

• Serve as Batch Release Officer reviewing documentation for dosage form batches and finished clinical trial packs.
• Assess QMS records (deviations, complaints) and recommend CAPAs.
• Review GMP documents (SOPs, Change Controls) from Clinical Supply Chain partners.
• Provide quality-related advice to business partner areas.
• Contribute to development of processes and procedures within Quality R&D Supply QA/QP US.
• Participate in audits/inspections and high-priority projects.
• Lead or contribute to continuous improvement initiatives.

Skills

GMP principles

QA review experience

Decision making

Education

Bachelor's degree or equivalent experience

Tools

Microsoft Office

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