QA Batch Review Specialist

The QA Specialist - Batch Review plays a critical role in supporting key Quality Assurance programs and ensuring the timely release of manufactured products. Working closely with the QA Supervisor, this position is responsible for the review and disposition of batch records, support of quality systems, and identification of operational and quality gaps.

This role serves as a champion of INCOG Bio Pharma's quality culture, driving efficiency, attention to detail, compliance, and on-time delivery. The ideal candidate thrives in a fast-paced GMP environment, balances independent decision-making with teamwork, and effectively collaborates with cross-functional stakeholders, clients, and regulatory partners.

• Perform full lifecycle review and disposition of parenteral manufacturing batch records for formulation, filling, inspection, and packaging activities for media fills and drug product.
• Provide client access and support during batch record review and approval processes.
• Support timely batch release activities by partnering with Quality Systems and Operations.
• Create and report batch release metrics to site leadership.
• Advise and approve batch record Bills of Material (BOMs) and Engineering Change Orders (ECOs).

• Support investigations into manufacturing and quality events, including root cause determination and mitigation planning.
• Participate in investigations involving major and critical deviations.
• Conduct preliminary evaluations of deviating events to determine impact, product segregation requirements, and immediate corrective actions.
• Escalate significant issues to management when appropriate.
• Support deviation investigations through root cause analysis, risk assessments, report writing, and mitigation development.
• Review plant automation alarms and support quality oversight activities.
• Author, review, and approve SOPs, work instructions, and related GMP documentation.

• Train QA Associates and Specialists on surveillance oversight and on-the-floor batch record review requirements.
• Support quality initiatives aimed at improving operational efficiency, compliance, and product quality.
• Analyze site trends using technical and statistical tools to identify sources of variability and process improvement opportunities.
• Promote a strong quality mindset and culture of continuous improvement.

• Utilize electronic and paper-based quality systems, including:
  • eDMS
  • SCADA
  • BMS
  • CMMS
  • LIMS
  • Laboratory Instrument Software
• Ensure data integrity and compliance with site procedures, quality standards, and regulatory requirements.

• Balance production schedules with quality and compliance requirements.
• Collaborate effectively with Operations, Quality Control, Engineering, Validation, and client teams.
• Influence positive outcomes through strong partnerships and technical expertise, regardless of reporting structure.
• Manage multiple priorities and projects in a fast-paced manufacturing environment.

• Demonstrate a proactive commitment to safety.
• Practice positive intervention and enforce compliance with SOPs, quality requirements, and site expectations.
• Support a culture focused on operational excellence, teamwork, and customer success.

• Bachelor's degree required, preferably in a scientific discipline such as:
  • Chemistry
  • Biology
  • Biochemistry
  • Microbiology
  • Or a closely related field

• Minimum 4 years of experience in a GMP-regulated environment.
• Minimum 2 years of experience supporting aseptic processing within cleanroom and/or isolator environments.
• Strong understanding of pharmaceutical manufacturing processes and batch review practices.

• Excellen…