Quality Assurance Representative

The QA Representative for the Floor Support team member provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities.  Advise and provide support for other floor support QA Representatives.  The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.   

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 

• Lead, mentor, and coach operations and support personnel on quality matters 

• Ensure regular presence in operational areas to monitor GMP programs and quality systems 

• Active on local process team, as outlined in MSOE standard, or indirect participation through project support activities 

• Ability to assess and triage deviations / observations that occur within the local process team 

• Work with Lilly support groups and external partners to resolve or provide advice on product related issues 

• Participate in self-led inspections and provide support during internal / external regulatory inspections 

• Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents) 

• Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization 

• Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function 

• Approve commissioning  qualification / validation documents for computer systems and equipment to ensure compliance with quality standards 

• Network with Global Parenteral Network sites as resources and benchmarking sources as applicable flexibility within job assignment 

Additional Preferences: 

• Demonstrate strong oral and written communication and interpersonal skills 

• Demonstrated decision making and problem solving skills 

• Demonstrate knowledge and understanding of manufacturing process and Quality Systems 

• Demonstrate technical writing and communication skills 

• Proven ability to work independently or as part of a team to resolve an issue 

• Strong attention to detail 

• Experience in GMP production environments or QCL is desirable 

• Previous experience with Lilly Event and Change Management processes 

• Proficiency with computer systems including Microsoft Office products, Regulus, TrackWise, PMX, and SAP 

Education Requirements: 

• Bachelors or equivalent (Science or Engineering related degree preferred). 

• Demonstrated equivalent experience in a GMP facility 

Other Information:  

• Overtime may be required. 

• May be required to respond to operational issues outside of core business hours / days. 

• Applicant may work in various areas within the Parenteral Plant.  Some allergens are present in the Parenteral Plant.  Mobility requirements and exposure to allergens should be considered when applying for this position. 

• May be subject to Post Offer Exam