Senior Quality Assurance Specialist Batch Disposition

Senior QA Specialist Batch Disposition

Who

INCOG Biopharma Services in Indianapolis, IN are looking for a Senior QA Specialist of Batch Disposition to join their rapidly growing team.

At INCOG, we are more than just a contract development and manufacturing organization. We are a company born out of a simple idea—that there has to be a better way. A better way to work with our customers. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.

Join us in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, our clients, and patients.

What

The Senior QA Specialist of Batch Disposition will help oversee review processes for Manufacturing Batch Record lifecycle activities, including Formulation, Filling, Inspection, Labeling and Packaging, and final-stage review and disposition. Working closely with the QA Batch Manager, the Senior QA 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. Valuing process owners and subject matter experts, they will possess a demonstrated ability in influencing positive outcomes without direct reporting authority

• 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.

You

Candidate 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.

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Curious? Send us your resume at ***email_hidden*** or you can find more information on our website.

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.