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 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 PR&D Quality Assurance Associate Consultant Analytical Primary Representative ensures continued organizational alignment with the business strategy and that laboratory activities conducted by PR&D and Collaboration Partners (CPs) are carried out in accordance with PR&D quality standards and/or are following current Good Manufacturing Practice (cGMP). This role is responsible for assuring the laboratory maintains a state of control with regards to the generation and reporting of analytical data. Primary loop responsibilities for the oversight of analytical data generated to support GMP operations for PR&D are required.

Key Responsibilities

1) Provide QA oversight for PR&D, PR&D CPs and PR&D GMP Service Providers as required.

2) Provide quality oversight commiserate with primary loop responsibilities, namely molecule support (internal and external testing labs), analytical equipment support, audit support, periodic lab walkthroughs, and quality assessments of quality documentations (e.g., TW1000 records)

3) Ensure that appropriate Quality Systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.

4) When necessary, evaluate potential impact of incidents on the quality of materials, or the integrity of data.

5) Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation.

6) Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred.

7) Be available for consultation on quality-related issues as needed.

8) Provide quality oversight to ensure compliance with internal standards and applicable regulations by maintaining a regular presence in PR&D areas and performing internal audits as scheduled.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or Engineering, or equivalent experience.

• Experience in Quality Assurance/Control, Technical Services, Laboratory, Development, or Manufacturing desirable.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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