QA Dry External Intermediates Manufacturing Associate
Join to apply for the QA Dry External Intermediates Manufacturing Associate role at Eli Lilly and Company.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life‑changing medicines while fostering a culture that puts people first.
Key Objectives/Deliverables
* Serve as a liaison between Contract Manufacturers (CMs) and Lilly.
* Provide quality oversight of CMs, being the initial point of contact for all quality‑related issues.
* Escalate quality issues at CMs to Lilly QA management.
* Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
* Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
* Provide quality oversight of Lilly/Dry‑EM Quality Plans.
* Coordinate and perform QA responsibilities of API shipments.
* Participate in regulatory inspection preparations with CMs and provide on‑site support during inspections.
* Participate on the Technical Review Board.
* Evaluate and disposition batches of intermediates, if required.
* Ensure that documented checks have been completed for Certificates of Testing and Environmental Monitoring, deviations, changes and batch documentation before batch release.
* Provide quality support of the manufacturing process for intermediates (e.g., Spry dry dispersion technology) with a holistic review of key activities impacting the process.
* Assess the impact of deviation investigations and changes, ensuring all appropriate records are documented and retrievable.
* Maintain all processes in an appropriate state of control.
* Maintain awareness of external regulatory agency findings pertaining to product quality.
* Review and approve documents such as procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
* Participate in APR activities.
* Participate in projects to improve productivity.
* Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
Basic Requirements
* BS in a science‑related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
* 3+ years of GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering.
Additional Preferences
* Experience in quality support for Quality Control activities.
* Thorough technical understanding of quality systems and regulatory requirements.
* Knowledge of pharmaceutical manufacturing operations.
* Demonstrated coaching and mentoring skills.
* Experience in root cause analysis.
* Demonstrated application of statistical skills.
* Strong written and verbal communication skills.
* Strong attention to detail.
* Proficiency with computer system applications.
* Excellent interpersonal and networking skills.
* Ability to organize and prioritize multiple tasks.
* Ability to influence diverse groups and manage relationships.
Additional Information
* Must complete required training for Dry‑EM Quality Assurance.
* No certifications required.
* Must be able to support 24‑hour/day operations.
* Willingness to travel, expected 30% travelling.
The anticipated wage for this position is $65,250 - $169,400. Full‑time employees are also eligible for a company bonus and a comprehensive benefits program, including 401(k) participation, health, dental, vision and prescription drug coverage, flexible benefits, and wellness resources.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. If you require accommodation as part of the application process, please visit https://careers.lilly.com/us/en/workplace-accommodation for assistance.
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