Specialist Quality Assurance

Responsibilities

• Provide quality oversight for commissioning, qualification, and process qualification of facilities, utilities, computer systems, and equipment, with cross-functional collaboration to ensure project timelines and milestones are achieved.
• Support Quality oversight for Commissioning & Qualification (C&Q) and validation activities at the site, including facilities/utilities, equipment/systems, computerized systems, process, and validation maintenance.
• Perform quality reviews of documents to support facility commissioning and qualification in line with project timelines, including:
  Commissioning/Qualification Protocols;
  Performance Qualification Protocols (PQ); review and approval of protocol discrepancies; and review of final reports and summary documents.
• Provide quality support during the execution of commissioning and qualification testing, reviewing and approving changes and discrepancies as required.
• Ensure all activities and related documentation for facilities, equipment, materials, and processes comply with applicable regulations and company requirements related to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Documentation Practices, Safety, and Controls; ensure documents comply with company procedures and regulatory expectations (e.g., FDA, EMA).
• 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.

• The annual salary for this position is between $35.00 - $45.00 per hour, depending on geography/market, skills, education, experience, and other qualifications of the successful candidate.
• Benefits include medical, dental, and vision insurance; 401(k) retirement plan; life insurance; long-term and short-term disability; paid time off, sick time, vacation, parental leave, paid holidays, paid parking/public transportation, and other applicable benefits.