Lilly Quality Assurance Associate-Analytical Product Development in Indianapolis, Indiana
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 39,000 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.
As a member of the Product Research and Development (PRD) organization, a Quality Assurance Associate- Analytical ensures continued organizational alignment with the business strategy and that laboratory activities conducted by PRD and CMOs are carried out in accordance with PRD quality standards and/or are in compliance with current Good Manufacturing Practice (cGMP). This role , you will be responsible for assuring the laboratory maintains a state of control with regards to the generation and reporting of analytical data. Internal inspections and auditing of PRD laboratories will be supported and performed by this position
Provide QA oversight for PR&D, PRD CMOs and PRD GMP Service Providers as required.
Ensure that appropriate Quality Systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.
When necessary, evaluate potential impact of incidents on the SISPQ of
materials, or the integrity of data.
Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results.
Review and approval of the corresponding documentation.
When necessary, notify management of quality issues.
Report and escalate decisions to the appropriate level. Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred.
Be available for consultation on quality-related issues as needed.
Provide quality oversight to ensure compliance with internal standards and applicable regulations by maintaining a regular presence in PRD areas and performing internal audits as scheduled.
Monitor effectiveness of implemented corrective actions and improvement initiatives.
Monitor trends in metrics of key quality systems (e.g. Deviations) to identify opportunities for CI/CAPA.
Provide Analytical QA oversight for executed activities for assigned molecules, including but not limited to method verifications, qualifications, validations, stability protocols, and technical reports.
Provide support to the Reference Standard area as required.
Bachelor's degree in Chemistry, Biology, Engineering, or Scientific Field
3+ years of experience in Quality Assurance/Control, Technical Services, Laboratory, Development, or Manufacturing.
Anunderstanding of the requirements of Regulatoryagencies such as the FDA,EMEA,ICH,OSHA and EPA particularly in the areaofcGMPs.
Additional Skills and Preferences
Previousdemonstration of making broad quality based-decisions in quality role (QA, QC).
Proficient with computer systems including Microsoft Office, Trackwise, SAP, etc.
Must be able to work and accomplishresultsindependently
Demonstratedproblemsolvingskills and a broadknowledge of analytical laboratories and quality systems.
Position Location: Indianapolis, IN
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!