QA Specialist

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

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