Sr. QA Specialist - Batch Release
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. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The batch disposition QA assures patients safe and drug products efficacious through effective quality oversight of the site.
The batch disposition QA is responsible for disposition of finished products. The batch disposition QA provides guidance to process team members for batch related issues, such as non-conformance investigations, issue resolution and other batch disposition activities.
Perform batch disposition of finished products to ensure high quality medicine is released to market in a timely manner.
Lead, mentor and coach operation and support personnel on quality matters associated with the batch / batch disposition.
Provide guidance in package area to ensure effectiveness of quality system and GMP compliance.
Provide support to quality management activities, which may include self-inspection, external quality audit, validation, and product recall.
Understand the results of on-going stability studies to ensure the results meet regulatory requirements and specification.
Be able to effectively review or approve documents to ensure quality attributes are met (e.g., deviations, procedures, protocols, specifications and change controls).
Participate in Six Sigma project or process improvement initiatives to improve productivity within the batch disposition.
Have an educational qualification of an undergraduate course or above in pharmacy, chemistry, biology, or related sciences.
At least five years of working experience in QA/QC
Proficiency with applicable computer systems
Demonstrate strong oral and written communication skills
Demonstrate interpersonal skills and ability to work as a team
Root cause analysis and troubleshooting skills
Demonstrate attention to detail and ability to maintain quality system
Capable of listening, speaking, reading and writing in English
Ability to work independently or as part of a team to resolve issues
Previous experiences with Lilly deviation and change management, preferred
Technical writing and communication skills
License pharmacist, preferred
Overtime may be required
May be required to respond to operational issues outside of core business hours/days
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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-21691.
Lilly is an EEO/Affirmative Action Employer and 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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