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Position Brand Description:

The Principal QA Associate– Qualified for Batch Release is responsible for final disposition of Active Pharmaceutical Ingredient (API) batches and Drug Substance Intermediates.  The The Principal QA Associate– Qualified for Batch Release ensures that all batches meet specifications, are manufactured in accordance with the validated process, are compliant with cGMP requirements and comply with regulatory commitments.

Key Objectives/Deliverables:

Provide quality support of API with the focus on holistic review of key activities associated with or impacting the manufacturing processes.Ensure that documented checks have been completed for the batch disposition checklist including but not limited to deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.Evaluate and disposition API batches and Drug substance Intermediates.Provide feedback, coaching and mentoring to QA personnel on the interpretations of Global Quality Standards and cGMPs/regulatory regulations.Holistically review the impact of all deviation investigations and major deviation investigations and change control with Batch Release Impact identified as “Yes” with emphasis on the cumulative impact to the product quality of batches. May involve participation on the Technical Review Boards for deviations and changes.Maintain awareness of internal audit findings and external regulatory agency inspections.May perform Stability Coordinator back-up role and have oversight of API stability program.Participate in the APR process.Provide support of internal audits and regulatory inspections.Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols, training documents), as applicable.Act as a liaison for US and OUS customers toward resolution of concerns from customers.Assist in the establishment and revisions of Quality Agreements with affiliates and customers.

Basic Requirements:

GMP manufacturing knowledge and/or experience.At least 5 years of Drug substance batch release experience

Additional Preferences:

Thorough technical understanding of quality systems and regulatory requirements.Demonstrated coaching and mentoring skills.Experience in root cause analysis.Experience in API or finished product manufacturing, QAExperience with system and equipment qualifications.Knowledge of cGMPs and quality systems.Demonstrated strong written and verbal communications skills.Strong attention to detail.Excellent interpersonal skills and networking skills.Ability to organize and prioritize multiple tasks.Demonstrated flexibility when faced with changing priorities.Proficiency with computer system applications and process automation systems.

Education Requirements:

BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences, related Life Sciences or previous GMP manufacturing knowledge and/or experience.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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