Senior QA Batch Disposition Specialist

About the Role

The Senior QA Batch Specialist will work closely with the QA Batch Manager to support major QA programs related to batch review, disposition, and continuous improvement. This role is key in championing and developing the organization’s Quality Mindset, fostering a culture of efficiency, attention to detail, and on-time delivery. The Specialist will identify and close Operational and Quality gaps while exemplifying excellent interpersonal skills to build productive, customer-centric relationships with colleagues, internal customers, and external partners.

The role requires strong written and oral communication skills to articulate complex issues clearly and concisely to diverse audiences. The Specialist will thrive in a team environment but also work autonomously, demonstrating self-management and organizational skills. They will influence positive outcomes without direct reporting authority and value collaboration with process owners and subject matter experts.

Responsibilities

• Lead full lifecycle review and disposition of parenteral manufacturing batch records (Formulation, Filling, Inspection, and Packaging) for Media Fills and Drug Product across all production stages.
• Perform formal batch disposition determinations by evaluating batch documentation, in-process and release testing results, CoA data, deviation investigations, and quality event closures to support release or rejection recommendations.
• Execute and document SQUIPP impact assessments for deviating events, applying ICH Q9 risk-based principles to provide scientifically defensible rationale in support of disposition decisions.
• Manage QA Hold status and serve as the primary QA point of contact for client-facing disposition communications, coordinating release timelines and documentation packages in accordance with QTA requirements.
• Coordinate with QC and Microbiology to ensure timely completion of all required release testing — including sterility, endotoxin/LAL, particulate matter, CCIT, and potency — and verify expiry dating and storage condition designations prior to final disposition.
• Support timely closure of batch-impacting deviations and participate in root cause investigations for Major and Critical events using formal RCA and risk analysis tools.
• Provide training to QA Associates and Specialists on batch record review, floor surveillance, and disposition workflows.
• Author, review, and approve SOPs and Work Instructions; advise on BOM/ECO builds and support Plant Automation alarm reviews.
• Maintain data integrity across site systems (Veeva, SCADA, BMS, CMMS, LIMS) and apply technical skills and applied statistics to track deviations and identify sources of process variability.
• Create and report batch release metrics to site leadership; model proactive safety behaviors and champion compliance best practices across teams.

Requirements

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Biochemistry, Microbiology, or related field) required.
• 7+ years of experience in a GMP environment, with a minimum of 5 years in aseptic processing within cleanroom and/or isolator environments.
• 5+ years of QA oversight experience encompassing aseptic manufacturing, full production stage batch record review, and formal batch disposition decision-making for sterile injectable drug products.
• 5+ years of experience as a performer or reviewer in QMS, DMS, Deviation/CAPA, and Change Control processes.
• Strong working knowledge of 21 CFR Part 211 (Subparts J and K), ICH Q10, and applicable regulations governing batch release, record retention, and product disposition.
• Demonstrated proficiency in SQUIPP impact assessment authoring, OOS/OOT result evaluation, QA Hold management, and QTA interpretation in support of batch disposition decisions.
• Familiarity with Annual Product Review (APR/PQR) processes and the contribution of batch disposition data to ongoing trend analysis and continuous improvement.
• Excellent written and verbal communication skills; proficiency with site systems and data analysis tools including SCADA, Word, Excel, Visio, JMP, and Minitab.

Preferred Qualifications

• 2 years of experience with assessment and review of Quality Control testing, CoA, and results management.
• Experience with client-facing batch release coordination in a CDMO environment, including management of release documentation packages and communication of disposition timelines to external sponsors.
• Familiarity with electronic batch record (eBR) systems and LIMS platforms as applied to batch disposition workflows.
• Experience with multi-product batch release programs supporting concurrent client campaigns in a contract manufacturing environment.

About the Company

At INCOG BioPharma, we have built a world-class CDMO for parenteral injectable drugs. Our culture prioritizes long-term value for customers through a service-oriented mindset, technical excellence, and a collaborative, team-centered approach. We are based in Fishers, IN, and maintain a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications. Qualified applicants must be authorized to work in the United States on a full-time basis; INCOG will not sponsor work authorization or visas for this role.