QA Specialist

Astek; Zebulon (NC); On-site; USD 70,000 - 105,000; Full time

Job summary

Astek in Zebulon, NC is hiring a QA Specialist to support quality and compliance for Investigational Medicinal Products distributed worldwide. This is a full-time, on-site role (first shift, 8:00 am to 5:00 pm).

The role requires reviewing GMP documentation, managing QMS records, and supporting regulatory inspections. Strong attention to detail and excellent communication are essential.

Qualifications

• Bachelor's degree or equivalent experience (5+ years in a similar role)
• QA review experience with GMP manufacturing/packaging documentation and/or laboratory records
• 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)

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
• 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

Education

Bachelor's degree

Tools

MS Office

Job description

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