At Lilly, we unite caring with discovery to make life better for people around the world. We are looking for people who are determined to make life better for people around the world.
Requirements
- Demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.
- Has experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools.
- Parenteral manufacturing experience
- A thorough understanding of cGMPs and drug product manufacturing.
- Solid technical writing skills.
- 2+ years of experience supporting manufacturing
Responsibilities
- Responsible for working with the Contract Manufacturer(s) (CM) to support supply, quality, and continuous process improvement of products that are supplied to Lilly sites and the market.
- Facilitate the Joint Process Team between Lilly and the Contract Manufacturer.
- Monitor and communicate monthly JPT metrics.
- Support Huddles with focus on KPIs with JPT Members.
- Foster and Support Strong Safety and Quality Cultures at the CMs.
- Provide day to day oversight of activities and resolution of issues taking place between the CMs and Lilly.
- Lead the resolution of manufacturing related issues including deviations/complaints and evaluation of manufacturing data and supply chain needs.
Other
- The Operations Associate is accountable to the Joint Process Team Leader.
- Support Launch/Divestiture Activities as needed.
- Develop effective and productive working relationships with colleagues at CM sites and at Lilly sites.
- Lead cross-functional/cross-site/cross-company project teams as needed.
- Make regular visits to CM to increase awareness of operations and maintaining strong working relationship.
