Representative-IDAP QA Engineer

2 weeks ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

At Lilly, the mission is to improve lives globally through groundbreaking discoveries in healthcare. Headquartered in Indianapolis, Indiana, Lilly is a leading healthcare company dedicated to developing life-changing medicines, advancing disease management, and supporting communities through philanthropy and volunteer work.

Overview:

The QA Engineer role at Lilly involves ensuring compliance with quality systems and GMPs for IDAP Operations. This pivotal position provides oversight of the Production Quality System, guiding activities such as change controls, equipment qualification, process validation, and more, while fostering close collaboration with Operations, Engineering, and Leadership.

  • Promote safety protocols
  • Maintain up-to-date training
  • Adhere to safety, quality, security, customer service, and GMP requirements
  • Offer guidance on qualification/validation, cleaning, production practices, deviations, and complaint management
  • Support introduction of new products in IDAP
  • Ensure quality standards are met for IDAP operations
  • Address critical issues promptly
  • Assess and bridge gaps between local and corporate standards
  • Keep the area audit-ready at all times
  • Assist in project timelines and continuous improvement efforts
  • Provide quality impact assessments and approvals
  • Stay informed about technologies, processes, and regulations
Basic Qualifications:Bachelor's Degree in STEM field3 years experience in GMP environmentAdditional Skills/Preferences:Prior experience in Quality Assurance or EngineeringKnowledge of cGMPs, Production Processes, Quality Systems, and FDA regulationsProficiency with relevant computer systemsExperience in root cause investigations, change management, and process validationEffective communication and problem-solving skillsAbility to lead and influence team dynamicsDetail-oriented with strong organizational skillsFlexibility in work hours and readiness for overtimeAdditional Information:Flexibility required for varying shiftsOvertime and weekend work may be necessaryTravel may be involvedCell phone availabilityAllergens present in the work environment

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