Onsite Qualification Specialist

Summit Human Capital•Richmond, VA

7d•Onsite

About The Position

Summit Human Capital is seeking a highly motivated Qualification Specialist to support our client in the manufacturing industry. This position has the exciting opportunity to support hands-on execution of equipment and process qualification activities, ensuring compliance and traceability within a regulated manufacturing environment.

Requirements

Bachelor's degree in a technical discipline (or equivalent hands-on qualification experience)
5+ years executing equipment qualification (IQ/OQ/PQ) and process validation in a GMP or regulated manufacturing environment
Demonstrated experience authoring and executing protocols and writing summary reports, including deviation/discrepancy documentation and traceability
Working proficiency with electronic quality systems (e.g., TrackWise or comparable eQMS), document management systems, and MS Office/Excel

Nice To Haves

Validation or quality certification (CQE, CQA, ASQ or similar)
Experience with documentation remediation and change-control linkage
Strong cross-functional coordination skills

Responsibilities

Draft, execute, and close out Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for manufacturing equipment and systems
Generate qualification reports, document results, and ensure full traceability of records in accordance with internal procedures and regulatory requirements
Coordinate closely with Manufacturing, Engineering, Quality, and Project teams to complete qualification testing around production windows
Support documentation remediation, record management, and change-control linkage for qualified equipment
Execute qualification deliverables with a focus on timely, right-first-time completion
Maintain compliance with GMP and internal quality standards