Sr Associate - QA Analytical 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. 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.

Basic Qualifications:

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

• Minimum 2 years of quality experience, (pharmaceutical experience preferred)

Additional Skills/Preferences:

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

Additional Info:

• This position is based in Indianapolis, IN and requires onsite presence the majority of the time (not remote).

• Business title may vary depending on leveling.

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