GMP Qualification Specialist: IQ/OQ/PQ Lead

Summit Human Capital; Richmond (VA); On-site; USD 55,000 - 63,000; Full time

Job summary

Summit Human Capital is seeking a Qualification Specialist to support client qualification activities in a regulated manufacturing environment. Responsibilities include drafting, executing, and closing IQ/OQ/PQ protocols for equipment and systems, generating qualification reports, and ensuring full traceability of records.

The ideal candidate has 5+ years of experience in equipment qualification and process validation, experience with eQMS, and strong documentation skills.

Qualifications

• Bachelor's degree in a technical discipline or equivalent hands-on qualification.
• 5+ years executing IQ/OQ/PQ and process validation in GMP/regulatory environment.
• Authoring and executing protocols; writing summary reports with deviation/discrepancy documentation.

Responsibilities

• Draft, execute, and close IQ/OQ/PQ protocols for equipment and systems.
• Generate qualification reports and ensure traceability of records.
• Coordinate with Manufacturing, Engineering, Quality, and Projects for qualification testing.
• Support documentation remediation and change-control linkage for qualified equipment.
• Execute deliverables with timely, right-first-time completion.
• Maintain GMP compliance and internal quality standards.

Skills

IQ/OQ/PQ

eQMS TrackWise

Documentation

MS Excel

Education

Bachelor's degree in technical discipline

Tools

TrackWise

MS Office

Job description

Summit Human Capital is seeking a Qualification Specialist to support client qualification activities in a regulated manufacturing environment. Responsibilities include drafting, executing, and closing IQ/OQ/PQ protocols for equipment and systems, generating qualification reports, and ensuring full traceability of records.

The ideal candidate has 5+ years of experience in equipment qualification and process validation, experience with eQMS, and strong documentation skills.