Onsite Qualification Specialist

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.