Senior QA Batch Disposition Lead — Parenteral Release

INCOG BioPharma Services; Fishers (IN); On-site; USD 90,000 - 140,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN seeks a Senior QA Batch Specialist to lead batch review and disposition across formulation, filling, and packaging, driving continuous improvement and the Quality Mindset.

The role requires strong QA oversight for aseptic manufacturing, experience with 21 CFR Part 211, QMS, CAPA, and data integrity across site systems; you will train QA staff and coordinate with clients to ensure compliant and timely releases.

Qualifications

• Bachelor's degree in Chemistry, Biology, Biochemistry, Microbiology, or related field.
• 7+ years GMP experience; 5+ years aseptic processing in cleanroom or isolator environments.
• 5+ years QA oversight in sterile product release and batch disposition.
• Experience with QMS, Deviation/CAPA, Change Control, and APR/PQR.
• Strong knowledge of 21 CFR Part 211 (Subparts J and K) and ICH Q10.

Responsibilities

• Lead full lifecycle review and disposition of parenteral batch records across production stages.
• Make disposition determinations based on documentation, testing, deviations, and closure data.
• Perform SQUIPP risk assessments to support disposition decisions.
• Coordinate QA Hold status and client-facing disposition communications.
• Ensure timely release testing with QC/Microbiology partners; verify expiry dating and storage designations.
• Contribute to root cause investigations for Major/Critical events.
• Train QA staff on batch review, surveillance, and disposition workflows.
• Review and approve SOPs and work instructions; support BOM/ECO and Plant Automation reviews.
• Maintain data integrity across site systems (Veeva, SCADA, BMS, CMMS, LIMS).
• Create and report batch release metrics to site leadership.

Skills

Batch disposition

Aseptic processing

QA oversight

QMS

Data integrity

Risk assessment

Communication

Cross-functional collaboration

Education

Bachelor's degree in sciences

Tools

SCADA

LIMS

JMP

Minitab

Excel

Word

Visio

Job description

INCOG BioPharma Services in Fishers, IN seeks a Senior QA Batch Specialist to lead batch review and disposition across formulation, filling, and packaging, driving continuous improvement and the Quality Mindset.

The role requires strong QA oversight for aseptic manufacturing, experience with 21 CFR Part 211, QMS, CAPA, and data integrity across site systems; you will train QA staff and coordinate with clients to ensure compliant and timely releases.