Quality Assurance Specialist
Target PR Range: 26-36/hr
*Depending on experience
• Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.
• Perform quality review of documents to support facility commissioning and qualification, according to project timelines.
o Commissioning / Qualification Protocols
o Performance Qualification Protocols (PQ)
o Review and Approval of protocol discrepancies
o Review of Final Reports and Summary Documents
• Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.
• Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
o Ensure documents comply with procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP).
• Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
• Participate in meetings related to document planning, execution, and issue resolution.
• Escalate any compliance concerns or critical gaps to QA management.
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
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