Quality Assurance Specialist

Overview

The QA will provide quality support and oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. They will collaborate cross-functionally to ensure project timelines and milestones are met.

• 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.
• Performance Qualification Protocols (PQ)
• Review and Approval of protocol discrepancies
• 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 company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Ensure documents comply with company 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.

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• Understanding of regulatory requirements, trends, and industry standards.
• Experience/knowledge in commissioning/qualification/validation, including computer-systems validation.
• Excellent written and verbal communication skills.
• Ability to work in a team matrix environment and build relationships with partners.
• Great attention to detail and high degree of accuracy in task execution and GMP documentation.
• Ability to complete tasks autonomously, providing updates to senior management, identifying potential issues, and following assignments through to completion.
• Proven capability and experience applying GMP requirements in an operational and Quality Control setting.