IS
Qualification Specialist
inSync Staffing Inc.
- 🇨🇦 Canada | 🇺🇸 United States
- On-site
- Mid level
- 20 hours ago
- GMP
- Technical Writing
- Regulatory Compliance
- Excel
- Health insurance
- Pension
20 hours ago
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
Overview 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.
Required Skills
- 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 TrackWise.
- 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 TrackWise 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.
Benefits (employee contribution):
- 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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Qualification Specialist · inSync Staffing Inc.