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Working closely with the QA Batch Manager, the Senior QA Batch Specialist will be instrumental in supporting major QA programs related to batch review, disposition and continuous improvement. They will also be key in championing and developing the organization's Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The Senior QA Specialist will at all times provide support with identifying and closing Operational and Quality gaps.

The Senior QA Specialist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and external partners and clients. The Senior QA Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Senior QA Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The Senior QA Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.

Essential Job Functions:

• 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.

Special Job 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.

Additional Preferences:

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

IAdditional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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