QA Batch Review & Disposition Manager

Overview

Starting your job search as a QA Batch Review leader? This could be a great opportunity to explore! This exciting chance to join the team is offered by INCOG Biopharmaceutical Services, a state of the art sterile injectable CDMO. INCOG has won the Best Places to Work in Indiana 4 years in a row, a testament to its culture and career opportunities.

This role involves close collaboration with the Senior Director of Quality and will be instrumental in championing and developing the organization's batch review excellence.

The role responsibilities are, but are not limited to:

• 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.
• Establish and maintain batch review procedures and checklists that ensure timely and accurate evaluation of all manufacturing batches while maintaining the highest quality standards.
• Lead investigation of manufacturing deviations and out-of-specification results, determining impact on product quality and appropriate corrective and preventive actions.
• Partner with Manufacturing Operations and Quality Control to review batch execution data, process parameters, environmental monitoring results, analytical testing data, CoA information, quality trends, and equipment performance records.
• Lead cross-functional batch review meetings to discuss complex cases, unusual events, and trending of quality data across product lines.
• 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.

• The ideal candidate 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.
• 3+ years of experience as a people leader or supervisor.
• Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing.
• Experience with regulatory inspections and ability to defend batch disposition decisions to regulatory authorities.
• (Preferred not essential) Hands-on experience with aseptic manufacturing Quality.
• (Preferred not essential) Isolator-based aseptic processing experience.
• (Preferred not essential) Experience with building processes and procedures.
• (Preferred not essential) Experience with Continuous improvement, Six Sigma, and/or Lean principles

Curious? Send us your resume at  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.