QA Batch Review & Disposition Manager

QA Batch Review & Disposition Manager

INCOG Biopharma Services in Indianapolis, IN is hiring a QA Batch Review & Disposition Manager. Working closely with the Senior Director of Quality, the Manager will be instrumental in championing and developing our new organizations batch review excellence and a culture of precision, scientific rigor, and timely product release decisions.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing. At INCOG, we are more than just a CDMO. We create meaningful experiences and a culture where everyone can thrive and succeed.

Job Functions

• Lead comprehensive batch record review processes for sterile injectable drug products, ensuring completeness, accuracy, and compliance with approved manufacturing procedures and specifications.
• Make critical batch disposition decisions (release, reject, or investigate further) based on thorough evaluation of manufacturing data, in?process testing results, and finished product testing.
• Ensure readiness for regulatory inspections by maintaining comprehensive batch files and being prepared to justify all disposition decisions to regulatory authorities.
• Train and develop team members on batch review processes, quality systems, and regulatory requirements specific to sterile injectable products.

Candidate Requirements

• Bachelors Degree required; preferred in Science (Chemistry, Biology, Biochemistry, Microbiology, etc.).
• Minimum of 6 years of Quality Assurance experience in pharmaceutical manufacturing with at least 4 years focused on batch review and disposition.
• Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing.
• 3+ years of experience as a people leader or supervisor.

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

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.

Senior Level: Mid?Senior level

Employment Type: Full?time

Job Function: Quality Assurance, Manufacturing, and Science

Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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