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QA Associate

Non-Headquarters

Valpro has several available opportunities supporting our world-class client sites or partner organizations.  Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

Quality Assurance Specialist (Contract)

Location: Exton, PA

Position Summary:

The Quality Assurance Specialist will support a GxP-regulated Life Sciences manufacturing environment, providing Quality Validation oversight for a new Advanced Therapy facility. This role supports clinical and commercial manufacturing operations, as well as in-process and analytical testing laboratories, ensuring compliance with global regulatory expectations including FDA, EMA, and ICH guidelines.

Responsibilities: 

  • Provide Quality Validation support for Life Sciences manufacturing operations, including cell therapy, gene therapy, biologics, or advanced pharmaceutical products.
  • Support validation activities in GMP manufacturing suites, cleanrooms, controlled environments, and QC laboratories.
  • Oversee and perform quality review and approval of Analytical Instrument Qualification (AIQ) and risk-based Commissioning & Qualification (C&Q) activities aligned with Life Sciences regulatory expectations.
  • Perform equipment and instrument release activities to enable GMP use for manufacturing, testing, and support operations.
  • Review and approve CMMS Change Controls, Work Order Cancellation/Deferment Forms, validation protocols, and lifecycle documentation in compliance with GxP requirements.
  • Partner with Engineering, QC, and Manufacturing teams to support instrument qualification (IQ/OQ/PQ) and process equipment validation.
  • Ensure validation documentation supports regulatory inspections, audits, and health authority readiness.
  • Perform quality review and approval of:
    • Risk assessments (FMEA, impact assessments)
    • Validation protocols and reports
    • SOPs, work instructions, and controlled documents
  • Support Computer System Validation (CSV) and Data Integrity initiatives in regulated Life Sciences systems.
  • Ensure all activities comply with Good Documentation Practices (GDP), data integrity principles (ALCOA+), and internal quality standards.

Qualifications:

  • Strong knowledge of Equipment Lifecycle Management processes.
  • Hands-on experience with validation and qualification of GxP laboratory and process equipment.
  • Experience reviewing and approving Standard Operating Procedures (SOPs).
  • Working knowledge of Computer System Validation (CSV) and Data Integrity principles.
  • Experience with Change Management processes.
  • Proficiency navigating and documenting activities within electronic quality systems in compliance with GDP.

Education:

  • Bachelor’s degree in engineering, life sciences, or a related technical/scientific discipline required.
  • Minimum of 5+ years of relevant industry experience in a regulated pharmaceutical, biotech, or a clinical manufacturing environment. 

This contract role is ideal for a Quality Validation professional looking to contribute to a cutting-edge clinical manufacturing organization while working within a highly regulated, collaborative environment.

 

Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net.  Any other domains are impersonations and should be ignored.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valpro is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

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