GMP QA specialist

Talent Groups; Zebulon (NC); On-site; USD 95,000 - 125,000; Full time

Job summary

Talent Groups is seeking a QA Specialist to ensure quality, safety, and regulatory compliance of Investigational Medicinal Products (IMPs) used in clinical trials worldwide. The role supports GMP compliance by reviewing documentation and participating in QMS activities, collaborating with cross-functional teams in a fast-paced pharmaceutical environment.

Onsite in Zebulon, NC, you will work with Manufacturing, Packaging, QC, and Regulatory Affairs to uphold company standards and drive continuous

Qualifications

• Bachelor’s degree or equivalent with 5+ years QA experience in GMP environments.
• Experience reviewing GMP manufacturing, packaging, or laboratory documentation.
• Strong understanding of GMP, Pharmaceutical Quality Systems, and documentation control.
• Experience supporting QMS activities: deviations, change controls, CAPAs, audits.

Responsibilities

• Review manufacturing and packaging documentation for IMPs to support batch release.
• Assess batch records, packaging, lab docs and finished packs for GMP compliance.
• Recommend batch release after verifying accuracy and regulatory fit.
• Ensure activities comply with SOPs, regulatory requirements, and quality standards.
• Participate in internal and external audits and regulatory inspections.
• Identify opportunities to improve quality processes and drive Lean/Six Sigma initiatives.

Skills

GMP knowledge

QA documentation review

Education

Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacy, or related field

Tools

Microsoft Office

Job description

The QA Specialist is responsible for ensuring the quality, safety, and regulatory compliance of Investigational Medicinal Products (IMPs) used in clinical trials worldwide. This role supports Good Manufacturing Practice (GMP) compliance by reviewing manufacturing, packaging, laboratory, and quality documentation, participating in Quality Management System (QMS) activities, and collaborating with cross-functional teams to ensure products meet regulatory and company quality standards. The position is fully onsite and requires strong attention to detail, sound decision-making, and the ability to work in a fast-paced, regulated pharmaceutical environment.

Key Responsibilities

Batch Release & Documentation Review

• Serve as a Batch Release Officer responsible for reviewing manufacturing and packaging documentation for investigational medicinal products.
• Review batch production records, packaging records, laboratory documentation, and finished clinical trial packs to ensure compliance with GMP requirements.
• Recommend batch release after confirming documentation accuracy, completeness, and regulatory compliance.
• Ensure all production activities comply with internal SOPs, regulatory requirements, and quality standards.

Quality Management System (QMS)

• Review and assess quality records including:
• Deviations
• Internal and third-party complaints
• Change Controls
• CAPAs (Corrective and Preventive Actions)
• Non-conformance investigations
• Perform root cause analysis and recommend appropriate corrective and preventive actions.
• Monitor implementation and effectiveness of CAPAs.

GMP Documentation

• Review and approve controlled GMP documents such as:
• Standard Operating Procedures (SOPs)
• Work Instructions
• Change Controls
• Quality Reports
• Controlled Forms
• Validation Documentation
• Ensure documentation follows company procedures and regulatory expectations.

Quality Support

• Provide quality guidance to Manufacturing, Packaging, Clinical Supply Chain, Logistics, and other business functions.
• Support continuous improvement initiatives to enhance quality systems and operational efficiency.
• Assist departments in resolving quality-related issues while maintaining GMP compliance.

Compliance & Regulatory Support

• Participate in internal and external audits.
• Support regulatory inspections conducted by agencies such as the FDA and other health authorities.
• Assist in preparing documentation and responding to audit observations.
• Ensure inspection readiness across quality systems.

Process Improvement

• Identify opportunities to improve quality processes.
• Participate in Lean, Six Sigma, or continuous improvement projects.
• Help standardize quality procedures and reduce compliance risks.

Cross-Functional Collaboration

• Work closely with:
• Manufacturing
• Packaging Operations
• Quality Control
• Clinical Supply Chain
• Regulatory Affairs
• Validation
• Logistics
• Communicate quality concerns and recommend practical solutions.

Required Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Biology, Pharmacy, or a related field, or equivalent experience (5+ years in a similar QA role).
• Experience reviewing GMP manufacturing, packaging, or laboratory documentation.
• Strong understanding of:
• Good Manufacturing Practices (GMP)
• Pharmaceutical Quality Systems
• Documentation review and approval
• Experience handling QMS activities such as:
• Deviations
• Change Controls
• CAPAs
• Complaints
• Audits and inspections
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Preferred Qualifications

• Experience supporting clinical trial manufacturing or pharmaceutical R&D.
• Knowledge of investigational medicinal products (IMPs).
• Experience working in highly regulated pharmaceutical or biotechnology environments.
• Ability to manage multiple priorities in a fast-paced setting.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.