Lilly
Healthcare
LeadProcessTechnician-QAFloorSupport
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“Lead Process Technician - QA Floor Support at Lilly. Skills: Quality Assurance, GMP, Aseptic manufacturing. Assure patients worldwide of safe and efficacious drug. Provide daily support and oversight to GMP operations”
Industry & Context.
Problem-solving skills
Work overtime, Mandatory overtime, Night shift, Rotating twelve hour day shift schedule
What They're Looking For.
Must Have
High School / GED minimum, Relevant pharmaceutical experience in aseptic manufacturing, Ability to work overtime, as requested
Nice to Have
Associates degree in a science, engineering, computer, or pharmaceutical related field, Experience in Production QA, QC, Experience in Visual Inspection, Experience with TrackWise Deviation and Change Management processes, Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field, Knowledge and understanding of pharmaceutical process and Quality Systems, Knowledgeable with inventory management systems and deviations systems, 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, Demonstrated decision making and problem-solving skills, Proven ability to work independently or as part of a team to resolve issues
What You'll Do.
Assure patients worldwide of safe and efficacious drug
Provide daily support and oversight to GMP operations
Support multiple production functions
Provide Quality oversight and guidance
Maintain a safe work environment
Support all HSE Corporate and Site Goals
Provide daily presence in operational areas
Monitor GMP programs and quality systems
Ensure adherence and understanding of good documentation practices
Ensure compliance with applicable procedures
and complete review of all
Coordinate delivery of reviewed paperwork
Support visual inspection AQL inspection
Review and approve GMP documentation
Initiate electronic batch record
Document quality on the floor oversight
Approve Maintenance action plans
Approve Return to Service and Release of equipment
Assess Work Orders and issue resolution
Identify potential product quality impact
Assess if Observations are required
Perform observational requirements for Aseptic Process Simulation 14-Day
Support observation during formulation and fill related aseptic
Provide QA systems support to reconcile issues in
Ensure all manufacturing areas receive QA support
How You'll Work.
Team & Collaboration
Work as a team member; Work within team
Communication Scope
Oral communication; Written communication; Interpersonal skills
Process & Methodology
Change Management
Full Job Description
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. The Lead Quality Assurance Floor Support Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of the site's Parenteral Operations activities. The Lead QA Floor Lead Tech is responsible for providing daily support and oversight to GMP operations in Raleigh-Durham North Carolina. The Lead QA Floor Support Lead Tech works as a team member supporting multiple production functions (formulation, filling, and visual inspection), from operations to maintenance, to achieve site goals while providing Quality oversight and guidance. **Job Responsibilities:** * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals * Provides daily presence in operational areas to: * Monitor GMP programs and quality systems and ensure adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel. * Monitors for, retrieves, and completes review of all paperwork in need of quality review in each area supported and coordinates delivery to the associated area when complete. * Supports visual inspection AQL inspection. * Review and approve GMP documentation in support of daily operations such as: * Cycle Summary Reports for equipment * Electronic batch record initiation * Daily documentation of quality on the floor oversight * Maintenance action plans
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