Lead Technician - QA - Floor - Night Shift

Role Summary

Lead QA Floor Support Technician (Night Shift) provides daily QA oversight to GMP operations at Indianapolis Parenteral Manufacturing, supporting multiple production functions from operations to maintenance to ensure safe, efficacious drug products and site goals with quality guidance.

Location:

Indianapolis, IN.

• 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
  • Track Wise
  • 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).

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

• High School Diploma or equivalent

• Strong interpersonal and teamwork skills
• Strong organization skills
• Strong written and verbal communication skills
• Ability to learn quickly and utilize new skills
• Attention to detail