QA Manager, Batch Review and Disposition

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\u00B7\u00A0\u00A0\u00A0\u00A0\u00A0\u00A0 Bachelor\u2019s Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)

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\u00B7\u00A0\u00A0\u00A0\u00A0\u00A0\u00A0 Minimum of 6 years of Quality Assurance experience in pharmaceutical manufacturing with at least 4 years focused on batch review and disposition.

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\u00B7\u00A0\u00A0\u00A0\u00A0\u00A0\u00A0 Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing.

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Working closely with the Senior Director of Quality, the Manager will be instrumental in championing and developing our new organization's batch review excellence and a culture of precision, scientific rigor, and timely product release decisions. The Manager will need to successfully lead comprehensive batch reviews, make critical disposition decisions, and ensure compliance with all regulatory requirements.

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The Quality Assurance Manager - Batch Review and Disposition will exemplify excellent analytical skills and develop productive, quality-focused working relationships with Manufacturing, Quality Control, , and cross-functional teams. The Manager will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex quality decisions and batch disposition rationales to a range of target audiences. The Manager will thrive in a team environment but will also work autonomously utilizing strong scientific judgment and decision-making skills.

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At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

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If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

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INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. \u00A0All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.