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Eli Lilly and Company · 18 hours ago

Computer Systems Quality Assurance Associate (Global)

Indianapolis, IN

Full-time

Hybrid

Entry Level

$65K/yr - $148K/yr

4+ years exp

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Computer Systems Quality Assurance Associate role is responsible for ensuring compliance with corporate Computer Systems Validation standards, maintaining inspection readiness, and providing quality oversight for IT systems.

BiotechnologyHealth CareMedicalPharmaceutical

No H1B

Responsibilities

Maintain Inspection Readiness 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

Deliver Projects, Programs, and Support 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

Streamline and Continuously Improve 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)

Grow Capabilities and Knowledge Share lessons learned and best practices with others

Support teammates by sharing experience, providing backup coverage, consulting, mentoring new CSQA Representatives, etc

Qualification

Computer Systems ValidationQuality AssuranceIT systems developmentSoftware development lifecycleProcess development methodologiesIT best practicesIT-control certificationsCommunication skillsInterpersonal interaction skillsMentoring skills

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