QA Validation Specialist- Isolator Qualification

Resolute Workforce Solutions (Staff augmentation subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective management of change. Our expertise is in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Project Management.

• Provide QA oversight for isolator qualification including IQ, OQ, PQ.
• Review and approve validation protocols, reports, deviations, and change controls.
• Assess qualification strategy for compliance with GMP and sterile manufacturing requirements.
• Make risk‑based QA decisions during execution of qualification activities.
• Support resolution of technical and compliance issues during commissioning and qualification.
• Partner with Validation, Engineering, Microbiology, and Operations teams.
• Escalate critical quality risks with clear rationale and documented impact assessment.
• Drive compliant, practical solutions to maintain schedule adherence.

• 5+ years of QA experience in GMP‑regulated pharmaceutical or biotech manufacturing.
• Direct sterile manufacturing experience.
• Hands‑on experience with isolator systems for aseptic processing.
• Strong background in reviewing and approving sterile validation documentation.
• Experience with deviation management, CAPA, and change control processes.
• Proven QA decision‑making authority in validation or qualification projects.
• Strong QA judgment in ambiguous situations with the ability to distinguish critical risks from administrative issues.
• Salary: CAD $100,000 – $130,000 (depending on experience).

• Isolator qualification lifecycle (IQ/OQ/PQ, smoke studies, airflow visualization, EM integration).
• Sterility assurance and contamination control strategy.
• Risk‑based validation aligned with FDA aseptic processing guidance, EU GMP Annex 1, and ICH Q9 Quality Risk Management.

• Life Insurance
• Accidental Death
• Long Term Disability
• Dental and Healthcare

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Qualification:

FIRST NAME, LAST NAME.

We thank all applicants in advance; however, we will only contact the candidates whose qualifications match closely to the job requirements.

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