Senior QA Associate, QC Lab - GMP Compliance Champion

BioSpace; Pleasant Prairie (WI); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

Bonus potential

401(k) plan

Comprehensive benefits

Paid time off

Job summary

Lilly is actively growing its manufacturing footprint and seeks experienced QA associates to support growth in Kenosha County, Wisconsin. The Senior Associate, Quality Assurance – QA for QC provides oversight of QC labs, handling non-conformance investigations, change controls, and qualification activities to ensure GMP compliance and inspection readiness.

Key duties include reviewing instrument commissioning, method transfers, validations, and supporting regulatory inspections.

Qualifications

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific Quality Control experience.
• On-site presence required.

Responsibilities

• Provides quality oversight to QC labs to ensure GMP compliance and readiness.
• Reviews and approves instrument commissioning and method transfers.
• Reviews method deliverables including transfers, verifications, and validations for QC lab systems and equipment.
• Maintains active presence in QC Lab areas to monitor GMP programs and quality systems.
• Supports regulatory inspections and site readiness efforts.
• Leads continuous improvement initiatives within the QC lab and quality organization.

Skills

Quality Assurance

GMP

cGMP

Leadership

Regulatory inspections

Root cause analysis

CSQA

LIMS

SAP

Veeva QMS

Veeva Quality Docs

LABVANTAGE

Education

Bachelor's degree in science/engineering/pharma

Tools

LIMS

LES

SAP

Veeva QMS

Veeva Quality Docs

LABVANTAGE

Job description

Lilly is actively growing its manufacturing footprint and seeks experienced QA associates to support growth in Kenosha County, Wisconsin. The Senior Associate, Quality Assurance – QA for QC provides oversight of QC labs, handling non-conformance investigations, change controls, and qualification activities to ensure GMP compliance and inspection readiness.

Key duties include reviewing instrument commissioning, method transfers, validations, and supporting regulatory inspections.