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 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. Job Description 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. Preferred Skills 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. Education Requirements 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. #IND1026