Eli Lilly and Company · 15 hours ago
Computer Systems Quality Assurance Associate (Global)
US, Indianapolis IN
Full-time
Hybrid
Entry Level
$65K/yr - $148K/yr
4+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on improving lives through innovative medicines. The Computer Systems Quality Assurance Associate role involves ensuring compliance with corporate Computer Systems Validation standards, providing quality oversight for systems, and maintaining inspection readiness.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Ensure supported systems remain validated per global policies and procedures
Track all quality actions and commitments in CAPA
Lead or participate in self-inspections, audits, and supplier assessments to assess validation status
Keep all inspection-readiness materials current and accurate
Provide periodic updates to key stakeholders
Escalate issues as appropriate
Provide consulting and interpretation of global CSV procedures for supported systems
Deliver IT Quality–related training as needed
Partner cross-functionally with Business, Business Quality, and Tech@Lilly to deliver value
Understand and align with customer, company, and Quality priorities
Review and approve documents within expected quality standards and timelines
Engage partners' and Quality management in appropriate discussions of risk
Ensure suppliers of computer systems or services meet quality expectations
Escalate computer system quality issues to the appropriate stakeholders
Strive for and promote consistency within the GISQ organization
Eliminate non-value added activities in order to focus on activities which continuously improve assurance of quality
Identify opportunity for streamlining and simplification and assist in developing improved solutions
Understand external trends and potential ramifications for the supported IT area(s)
Share lessons learned and best practices with others
Support teammates by sharing experience, providing backup coverage, consulting, mentoring new CSQA Representatives, etc
Qualification
Required
Bachelor's degree – Preferred in a technology related field (i.e. Computer Science) or High School Diploma with 4 years of IT or Quality experience in a regulated industry
All CSQA Representatives must complete Lilly's CSQA Qualification Program, including AI CSQA Certification
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
Preferred
Prior experience in IT systems development experience or QA
Proficiency with the software development lifecycle
Strong verbal and written communication, interpersonal interaction skills, and ability to influence and collaborate
Proficiency with Computer Systems Validation and demonstrated ability to right-size validation based upon risk
Understanding of process development and/or improvement methodologies
Knowledge of multiple Lilly business areas
Broad IT technical competency
Knowledge of IT best practices (e.g., ITIL)
Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))
Benefits
Company bonus
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-12
2026-01-12
Company data provided by crunchbase