Senior Associate

1 day ago

Lebanon, Pennsylvania, United States Eli Lilly Full time
Job Summary

We are seeking a highly skilled Data Integrity Quality Assurance Specialist to join our team at Eli Lilly. As a key member of our quality assurance team, you will be responsible for ensuring the integrity of our computer systems and data.

Responsibilities
  • Deliver on CSV processes and Data Integrity Sustainability
  • Establish and maintain CSQ support and DI sustainability processes
  • Drive appropriate consistency in CSQ and DI controls
  • Deliver Projects and Programs
  • Understand and maximize business value of Data integrity controls in computer systems
  • Understand customer, company, and Quality priorities, and support implementation goals
  • Provide consulting and right-sizing of DI activities for GMP computer systems based on risk and value
  • Provide linkages to partner organizations with CSV and DI including Automation, Site C&Q, BQA, and other CSQA persons
  • Grow Capabilities and Knowledge
  • Mentor others in DI and CSV-related roles
  • Maintain Inspection Readiness
  • Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the LP1 facility
  • Provide cross-functional technical leadership in the event of serious quality-related issues with computer systems or data integrity
  • Monitor current state of inspection-readiness
  • Escalate issues appropriately
  • Streamline and Continuously Improve
  • Promote common process and best practice across functions
  • Identify systemic issues and trends across functions and drive improvement activity
  • Understand the external environment/best practices and bring external learning back to Lilly
Requirements
  • Bachelor's degree in Computer Science, Engineering, Mathematics, Life Sciences, or a technology-related field
  • 1+ year of experience in Automation/QC Labs/IT, Quality, or computer system validation in the pharmaceutical industry
Preferred Qualifications
  • Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+)
  • Previous experience in GMP or GLP environments
  • Demonstrated strong oral and written communication skills
  • Strong interpersonal interaction skills
  • Proven ability to influence quality peers, IT SMEs, and upper management
  • Previous experience in Business Quality Assurance and Automation
  • Understanding of process development and/or improvement (e.g. Six Sigma)
  • Knowledge of Lilly business area and its impact to products and patients

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