Senior Microbiology QA Lead

Cardinal Health; Kentucky; On-site; USD 80,900 - 103,950; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k plan

Paid time off

HSA

Disability coverage

Parental leave

Job summary

Cardinal Health is seeking a highly skilled Microbiology Principal Specialist to join the Quality Assurance team supporting PET facilities and the microbiology laboratory.

You will lead investigations, drive CAPAs, review deviations, and ensure data integrity and inspection readiness while collaborating with cross‑functional groups to improve manufacturing readiness and product safety.

Qualifications

• Bachelor's degree in microbiology or related field required.
• 4–8 years of experience in a cGMP environment preferred.
• Strong understanding of cGMP concepts and QA principles.
• Excellent technical writing and communication skills.

Responsibilities

• Author, review and manage deviations, CAPAs, and technical reports to ensure cGMP compliance.
• Lead investigations (OOS/trend) and drive root cause analysis with effective CAPAs.
• Review environmental monitoring data and escalate negative trends.
• Collaborate with Manufacturing, QA, Engineering, Validation and Training teams.
• Ensure data integrity and GDP compliance across documentation.

Skills

cGMP knowledge

Investigations leadership

Data integrity

Technical writing

Cross-functional collab

Veeva proficiency

SAP ERP

GDP understanding

Education

BSc in Microbiology

Tools

Veeva

SAP

Job description

Cardinal Health is seeking a highly skilled Microbiology Principal Specialist to join the Quality Assurance team supporting PET facilities and the microbiology laboratory.

You will lead investigations, drive CAPAs, review deviations, and ensure data integrity and inspection readiness while collaborating with cross‑functional groups to improve manufacturing readiness and product safety.