Lead Technician - QA - 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.

Company Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities

The Quality Assurance Floor Support Team assures patients worldwide of safe and efficacious drug products, through effective quality oversight of Indianapolis Parenteral Operations activities.

The QA Floor Support Lead Technician (Night Shift) is responsible for providing daily support and oversight to GMP operations at Indianapolis Parenteral Manufacturing. The QA Floor Support Lead Technician works as a team member supporting multiple production functions, from operations to maintenance, to achieve site goals while providing Quality oversight and guidance.

• Responsible for maintaining a safe work environment, leading safety initiatives, and 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.
• Review and approve GMP documentation in support of daily operations such as:
  • Maintenance Action Plans
  • Return to Service and Release of equipment, product, and area HOLDs
  • Cycle Summary Reports for equipment
  • Ticket Check - In
  • Work Order assessments and issue resolution
  • Release of Sanitization Agents and pH Adjusters
  • Other documents as required.
• Provide guidance and assistance in identifying potential product quality impact and assessing if Observations are required.
• Performs observational requirements for Aseptic Process Simulation 14-Day Reads and supporting observation during formulation and fill related aseptic activities.
• Provide QA systems support to reconcile issues in multiple systems such as:
  • LMS
  • PMX
  • TrackWise
  • EDMS
  • GMARS
  • And other systems as required.
• Work within QA Lead Technician team to ensure all manufacturing areas receive QA support needed to maintain daily operations.
• Reviews GMP documents (e.g., Procedures, Protocols, and Production Record Instructions).

Basic Requirements

• High School Diploma or equivalent
• Experience working in a GMP facility
• Experience with computer systems including Microsoft Office products, LMS, Darwin, TrackWise, Veeva Vault, and PMX.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

Additional Preferences

• Demonstrated relevant experience in a GMP facility
• Demonstrated strong interpersonal skills and the ability to work as a team
• Demonstrated organization skills
• Demonstrated ability to learn quickly and utilize new skills
• Proficiency with computer systems including Microsoft Office products, LMS, Darwin, TrackWise, Veeva Vault, and PMX.
• Night Shift schedule flexibility.
• 3+ years of parenteral manufacturing experience
• Strong oral and written communication and interpersonal skills
• Strong attention to detail
• Experience in Production QA, QC is desirable
• Experience with TrackWise/Veeva OneQMS Deviation and Change Management processes.

Other Information

• Applicant may work in various areas within the Parenteral Plant.  Some allergens are pres