QA Batch Review Specialist

The QA Batch Review Specialist will support major QA programs, champion the organization's Quality Mindset, and develop a culture of efficiency, attention to detail, and on-time delivery. They will work closely with the QA Supervisor and provide support with identifying and closing Operational and Quality gaps.

Requirements

• Full lifecycle review and disposition of parenteral manufacturing Batch Records
• Provide Client access and support in the review and approval of Batch Records
• Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements
• Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities
• Create and report batch release metrics to site leadership
• Participate in operations investigations for determining root cause and assessing mitigation for Major and Critical deviating events
• Support authoring, reviewing and approving of various SOPs & Work Instructions
• Support Plant Automation alarm reviews
• Advise and approve the builds of Batch Record BOMs and ECOs
• Prioritize and coordinate their time in balancing production timelines with product quality assurances
• Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events
• Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools
• Utilize various paper and automated systems to ensure data integrity for site policies, procedures, and batch records
• Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes
• Ability to manage multiple projects in a fast-paced environment
• Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement
• Relocation Assistance