Process Technician - Quality Assurance Floor Support (Night Shift)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Description:

The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the QA Floor Support Supervisor. QA Floor Support Specialist is responsible for providing support and QA oversight to GMP operations in the Device Assembly and Packaging (DAP) area.  The QA Floor Support Specialist supports multiple production functions (from operations to maintenance) to achieve site goals while providing Quality oversight and ensuring compliance.

Key Objectives/Deliverables: 

• Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals. 

• Responsible for ensuring training is completed and remains in compliance. 

• Communicates with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues. 

• Ensures 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. 

• Ensures regular presence in device assembly and packaging areas to monitor GMP programs and quality systems. 

• Reviews and approves GMP documentation in support of daily operations such as: Electronic Logs, and Other documents as required. As well as performing daily Quality Checks. 

• 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. 

• Perform collection, visual inspection and delivery of samples both in person and Electronically (Darwin) 

• Ability to work cross functionally and work collaboratively with all levels of the organization. 

Basic Requirements: 

• High School Diploma or equivalent

• 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.

Additional Preferences: 

• Completion of Post Offer Exam or Completion of Work Simulation if applicable. 

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.

• 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 en