QA Batch Review & Disposition Manager

QA Batch Review & Disposition Manager

WHO?

INCOG Biopharma Services in Indianapolis, IN is hiring a QA Batch Review & Disposition Manager who will be working closely with the Senior Director of Quality. They will be instrumental in championing and developing the organization's batch review excellence. This role offers the opportunity to work at INCOG’s state-of-art sterile injectable CDMO during an exciting time of growth, contributing towards a better path to market for life-saving drugs.

WHAT?

This role will need to successfully lead comprehensive batch reviews, make critical disposition decisions, and ensure compliance with all regulatory requirements.

• Lead comprehensive batch record review processes for sterile injectable drug products, make critical batch disposition decisions (release, reject, or investigate further), establish/maintain batch review procedures & checklists, and lead associated investigations
• Maintain batch disposition databases and generate reports on batch release metrics, cycle times, and quality trends for senior management.
• Train and develop team members on batch review processes, quality systems, and regulatory requirements specific to sterile injectable products.

YOU!

Ideally, candidates will have a Bachelor’s degree in Science (Chemistry, Biology, Biochemistry, Microbiology), along with 6 years of QA experience in pharmaceutical manufacturing focusing on batch review & disposition.

• Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing
• Around 3 years of supervisory/ people leadership experience

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

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.