Senior QA Associate, QC Lab – Compliance & Readiness

Regulatory Jobs

Pleasant Prairie (WI)

On-site

USD 66,000 - 172,000

Full time

2 days ago

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Job summary

Lilly Kenosha County, Wisconsin is seeking a Senior Associate, Quality Assurance – QA for QC to provide quality oversight in the QC Laboratory, ensure GMP compliance, and support validation activities as Lilly expands its manufacturing footprint.

You will lead QC lab personnel, review instrument qualifications, support change controls, deviations, and regulatory inspections, and collaborate with global QC teams to drive continuous improvement.

Qualifications

Bachelor’s degree in science, engineering, or pharmaceutical-related field, or equivalent experience.
Minimum 5 years in the pharmaceutical industry with QC experience.
On-site presence required.
Demonstrated understanding of cGMP regulations.
Experience with LIMS, LES, SAP, Veeva QMS, or related systems.
Strong written and verbal communication skills.

Responsibilities

Maintain a safe work environment and lead safety initiatives.
Lead and mentor QC lab personnel on quality matters.
Support QA Compliance and site readiness with right-first-time QC execution.
Review and approve instrument commissioning and qualification deliverables.
Review and approve method transfers, verifications, and validations for QC lab systems.
Ensure presence in QC Lab areas to monitor GMP programs and quality systems.
Participate in Lean Lab initiatives and continuous improvement.
Assess and triage deviations in Quality Control.
Collaborate with support groups and external partners on QC issues.
Participate in self-led inspections and regulatory inspections support.
Coordinate with Global QC labs to replicate best practices.
Author/review GMP documents in QC for quality attributes.
Drive continuous improvement to boost productivity in quality teams.