About The Position

The Technician Warehouse Quality Assurance works as a member of the Warehouse QA team. Process Technician is responsible for providing support and QA oversight to GMP operations in the Warehouse and Logistics area. The Technician supports multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensuring compliance.

Requirements

  • High School Diploma or equivalent.
  • Demonstrated decision making and problem-solving skills.
  • Strong attention to detail.
  • Proven ability to work independently or as part of a team to resolve issues.
  • Ability to work overtime, as requested.
  • Demonstrated strong oral and written communication and interpersonal skills.
  • Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
  • Proficiency with inventory management systems and deviations systems (i.e. SAP, Darwin, etc.).
  • Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
  • Previous experience in GMP production environments.
  • Previous facility or area start up experience.
  • Knowledge of Validation / Qualification activities.

Nice To Haves

  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Responsibilities

  • Adhere to safety rules and maintain a safe work environment for both self and others by supporting HSE corporate and site goals.
  • Ensure training is completed and remains in compliance.
  • Ensure adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
  • Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.
  • Ensure regular presence in warehouse and logistics areas to monitor GMP programs and quality systems.
  • Review and approve GMP documentation in support of daily operations such as Electronic Logs and other documents as required.
  • Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, EWM, Darwin and other systems as required).
  • Participate in self-led inspections and provide support during internal/external regulatory inspections.
  • Work cross-functionally and collaboratively with all levels of the organization for metrics reviews, operational support, and issue/deviation management.

Benefits

  • Eligibility to participate in a company-sponsored 401(k); pension.
  • Vacation benefits.
  • Eligibility for medical, dental, vision and prescription drug benefits.
  • Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
  • Life insurance and death benefits.
  • Certain time off and leave of absence benefits.
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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