QA Batch Review Specialist

About the role

The QA Specialist – Batch Review will work closely with the QA Supervisor to support major QA programs, champion the organization’s Quality Mindset, and foster a culture of efficiency, attention to detail, and on-time delivery. This role involves identifying and closing Operational and Quality gaps while developing productive, customer-centric relationships with colleagues, internal customers, and external partners. The Specialist will demonstrate excellent written and oral communication skills, thrive in a team environment, and work autonomously with strong self-management and organizational abilities.

Responsibilities

• Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
• Provide Client access and support in the review and approval of Batch Records.
• Train QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements.
• Support Quality Systems in driving timely completion of batch-impacting deviations to ensure on-time batch release.
• Create and report batch release metrics to site leadership.
• Participate in operations investigations to determine root cause and assess 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 balance production timelines with product quality assurances.
• Exercise rapid decision-making in evaluating the scope and impact of deviating events, product segregation requirements, and implementation of initial corrective actions or escalation to management.
• Provide cross-functional support in deviation investigative processes using root cause analysis tools, report writing, and mitigation development with risk analysis tools.
• Utilize paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software) to ensure data integrity for site policies, procedures, and batch records.
• Apply technical skills and statistics to analyze and track deviations, identifying sources of variability and error in site processes.
• Manage multiple projects in a fast-paced environment.
• Exemplify proactive safety approaches, practice positive intervention, and enforce best practices aligned with SOPs, compliance requirements, quality guidelines, and site goals.

Requirements

• Bachelor’s Degree required (preferred in a related Science such as Chemistry, Biology, Biochemistry, or Microbiology).
• 4 years minimum experience working in a GMP environment.
• 2 years minimum experience working with aseptic processing in cleanroom and/or isolator environments.
• Excellent written and verbal communication skills.
• General computer skills, including hands-on experience with computerized Operations equipment (SCADA) and reporting/data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Preferred Qualifications

• 3 years experience as a performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control.
• 2 years’ experience with assessment and review of Quality Control testing, CoA, and results management.
• Extensive knowledge of regulations and quality processes involving product disposition.

All positions are based in Fishers, IN. Candidates must be authorized to work in the United States on a full-time basis; INCOG will not provide sponsorship for work authorization or visas for this role.