Microbiology QA Lead - Lab Excellence & Compliance

Cardinal Health; Legendary Hills (IN); On-site; USD 107,000 - 152,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day (myFlex

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Job summary

Cardinal Health is seeking a Quality Assurance leader to oversee microbiology laboratory systems and environmental monitoring, ensuring compliance with 21 CFR rules and company policies. The role emphasizes implementing quality policies, driving improvements, and collaborating across functions to deliver reliable, safe, and effective products.

You will manage budgets and guide personnel while advancing laboratory testing, validation, and risk assessment.

Qualifications

• BS in Microbiology, Biology, or related science field; advanced degree preferred.
• Experience with 21 CFR 210/211 in FDA-regulated industry (Pharmaceutical or Medical Device).
• Experience with equipment qualification, software validation, test method validation, environmental monitoring, and/or process validation.
• Strong technical writing skills and ability to write procedures/reports.

Responsibilities

• Oversees microbiology laboratory systems and data per regulations.
• Manages Environmental Monitoring Program and lab testing.
• Conducts laboratory investigations and leads CAPA efforts.
• Trains and develops laboratory personnel; manages resources and budget.

Skills

Teamwork

Attention to detail

Technical writing

MS Word

MS Excel

Education

BS in Microbiology

Advanced degree preferred

Tools

Equipment qualification

Software validation

Test method validation

Environmental monitoring

Process validation

Job description

Cardinal Health is seeking a Quality Assurance leader to oversee microbiology laboratory systems and environmental monitoring, ensuring compliance with 21 CFR rules and company policies. The role emphasizes implementing quality policies, driving improvements, and collaborating across functions to deliver reliable, safe, and effective products.

You will manage budgets and guide personnel while advancing laboratory testing, validation, and risk assessment.