Quality Assurance Associate Consultant

4 days ago


Marquand, Missouri, United States Eli Lilly Full time
Job Summary

We are seeking a highly skilled Quality Assurance Associate Consultant to join our team at Eli Lilly. As a Primary Representative, you will be responsible for ensuring the laboratory maintains a state of control with regards to the generation and reporting of analytical data.

Key Responsibilities
  • Quality Oversight: Provide QA oversight for PR&D, PR&D CPs, and PR&D GMP Service Providers as required.
  • Quality Systems: Ensure that appropriate Quality Systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards.
  • Incident Evaluation: Evaluate potential impact of incidents on the quality of materials, or the integrity of data.
  • Investigations: Ensure appropriate investigations are conducted for deviations, stability failures, and out of specification (OOS) results.
  • Documentation Review: Perform Quality Assurance review and/or approval/rejection of GMP documentation.
  • Consultation: Be available for consultation on quality-related issues as needed.
  • Compliance: Provide quality oversight to ensure compliance with internal standards and applicable regulations.
Requirements
  • Education: Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or Engineering, or equivalent experience.
  • Experience: Experience in Quality Assurance/Control, Technical Services, Laboratory, Development, or Manufacturing desirable.


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