Onsite Qualification Specialist

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 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

• 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

Desired

• 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

The hourly pay range for this position is $40 - $46, depending on experience, skills, and qualifications.

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.