Senior QA Batch Disposition Lead | Precision & Compliance

INCOG BioPharma; Fishers (IN); On-site; USD 120,000 - 170,000; Full time

Job summary

INCOG BioPharma in Fishers, IN is seeking a Senior QA Batch Specialist to lead batch review, disposition and continuous improvement efforts for parenteral products. You will drive QMS improvements, mentor QA staff, and coordinate with QC, Microbiology, and plant operations to ensure on-time batch release.

The role emphasizes risk-based decision making, data integrity across site systems, and strong communication with internal and external partners to uphold quality standards.

Qualifications

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Biochemistry, Microbiology, or related field) is required.
• 7+ years in a GMP environment with at least 5 years in aseptic processing within cleanroom/isolation environments.
• 5+ years of QA oversight encompassing aseptic manufacturing, batch record review, and disposition decisions for sterile products.
• 5+ years in QMS, DMS, Deviation/CAPA, and Change Control processes.
• Strong knowledge of 21 CFR Part 211 (Subparts J and K) and ICH Q10.
• Proficiency in SQUIPP, OOS/OOT evaluation, QA Hold management, and QTA interpretation.
• Experience with APR/PQR processes and trend analysis.

Responsibilities

• Lead full lifecycle review and disposition of parenteral batch records across production stages.
• Perform batch disposition determinations using documentation, tests, deviations, and closures.
• Execute SQUIPP impact assessments applying risk-based principles.
• Manage QA Hold status and client-facing disposition communications.
• Coordinate release testing with QC/Microbiology and verify expiry dating and storage designations.
• Close deviations and participate in RCA and risk analysis for Major/ Critical events.
• Provide training to QA staff on batch review, surveillance, and workflows.
• Author and review SOPs and plant automation considerations.
• Maintain data integrity across site systems (Veeva, SCADA, BMS, CMMS, LIMS).
• Create and report batch release metrics to site leadership.

Skills

QA oversight

GMP compliance

SQUIPP

Root cause analysis

Statistical analysis

Batch disposition

Client communication

Training

Education

Bachelor's in science

Tools

Veeva

SCADA

BMS

CMMS

LIMS

Job description

INCOG BioPharma in Fishers, IN is seeking a Senior QA Batch Specialist to lead batch review, disposition and continuous improvement efforts for parenteral products. You will drive QMS improvements, mentor QA staff, and coordinate with QC, Microbiology, and plant operations to ensure on-time batch release.

The role emphasizes risk-based decision making, data integrity across site systems, and strong communication with internal and external partners to uphold quality standards.