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Onsite Qualification Specialist
Job Location:
Job Location:
Richmond, VA - USA
Hourly Salary:
USD 40 - 46
Hourly Salary:
Posted:
29 September 2026 (4 days ago)
Posted:
Application Deadline:
27 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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. The ideal candidate will meet the following criteria:
Requirements:
Benefits: We offer a comprehensive benefits package which includes medical dental and vision insurance; 401(k)/retirement plan; and other benefits in accordance with applicable laws.
Requirements:
- Bachelors 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
- Validation or quality certification (CQE CQA ASQ or similar)
- Experience with documentation remediation and change-control linkage
- Strong cross-functional coordination skills
- 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
Benefits: We offer a comprehensive benefits package which includes medical dental and vision insurance; 401(k)/retirement plan; and other benefits in accordance with applicable laws.
Required Experience:
IC
