Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.
Requirements
- Demonstrated relevant experience in a GMP facility.
- Parenteral visual inspection experience
- Previous experience with deviation and change control process.
- Experience in Production, QC, QA, Technical Services, or Regulatory
- Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
- Experience as mentor or trainer
- Strong technical writing and oral/written communication skills
Responsibilities
- Responsible for Syringe Defect Kit Management, including Automated Inspection Challenge kits, and Inspection Qualification kits.
- Review GMP documents (example: Non-conformances, procedures, protocols, and change controls).
- Evaluate potential Product Quality impact for any GMP-related incident and support the investigations and assist with Safety investigations.
- Ensure Good Documentation practices and compliance with operational procedures and work instructions with Operations and support personnel.
- Perform inspection of Syringes.
- Participates in Six Sigma Projects and Process Improvement Initiatives to improve productivity within the Quality organization and the process team.
- Provide oversight and assist with training of new Parenteral site visual inspectors.
Other
- Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
- Capable of functioning in Leader capacity in absence of Leader.
- Assist Leader in development of QA Stat Sort Assistants.
- High School diploma or equivalent
- Demonstrated strong interpersonal skills and the ability to work as a TEAM.
