Qualification Specialist

Job Title: Qualification Specialist
Pay: $50.00–$53.33/hour (W2)
Hours: Monday–Friday, 8:00 AM–5:00 PM
Location: Richmond, VA 23234 | Onsite
Duration: 6 month contract

We are seeking an experienced Qualification Specialist to support hands‑on equipment qualification and process validation activities in a regulated manufacturing environment. This role focuses on executing IQ/OQ/PQ protocols, preparing technical documentation, and ensuring compliance with quality and regulatory standards.

• 5+ years of hands‑on equipment qualification (IQ/OQ/PQ) and process validation experience.
• Experience working in GMP or other regulated manufacturing environments.
• Strong technical writing skills, including protocol development, execution reports, and deviation documentation.
• Knowledge of change control, documentation traceability, and regulatory compliance.
• Experience with electronic quality management systems (eQMS), such as Track Wise.
• Ability to work independently and coordinate with cross‑functional teams on an active manufacturing floor.

• Draft, execute, and close out Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols.
• Conduct qualification testing for manufacturing equipment, systems, and processes.
• Prepare qualification reports and maintain accurate, GMP‑compliant documentation.
• Document deviations, discrepancies, testing results, and corrective actions.
• Maintain qualification records, traceability, and change‑control documentation.
• Collaborate with Manufacturing, Engineering, Quality, and Project teams to coordinate testing around production schedules.
• Support documentation remediation and ensure timely completion of qualification deliverables.

• Experience with Track Wise or comparable eQMS platforms.
• Proficiency in Microsoft Office, Excel, and electronic document management systems.
• Quality or validation certifications such as CQE, CQA, or ASQ.
• Experience executing qualification protocols in live production environments.

• Bachelor's degree in Engineering, Science, or a related technical discipline preferred.
• Equivalent hands‑on equipment qualification and validation experience will be considered in lieu of a degree.

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.

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