Senior Microbiology QA & Lab Operations Lead

Regulatory Toolkit; Indianapolis (IN); On-site; USD 107,000 - 152,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k savings plan

Paid time off

HSA

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Wellness programs

Job summary

Cardinal Health is seeking a Quality Assurance leader to develop and implement compliant, cost-effective quality systems ensuring products and services meet regulatory standards. The role oversees microbiology lab activities, training, and governance of quality policies to support safe, effective products.

You will manage department operations, supervise staff, and drive continuous improvement in processes.

Qualifications

• B.S. degree 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.
• Understanding of Validation and Technology Transfer processes; experience writing procedures/reports.
• Strong teamwork and communication skills; ability to multi-task.
• Proficiency in Microsoft Word and Excel; strong technical writing skills.

Responsibilities

• Oversee microbiology lab systems to ensure regulatory compliance and policy adherence.
• Maintain Environmental Monitoring Program per requirements.
• Collaborate with validation and maintenance teams on equipment conformity.
• Inspect, investigate, and sample to monitor factors affecting product quality.
• Ensure testing is performed and records evaluated.
• Lead training and development for lab personnel.
• Ensure safety, quality, and escalation processes are followed.

Skills

Quality systems

Regulatory compliance

Team collaboration

Technical writing

MS Word/Excel

Education

B.S. in Microbiology/biology or related science

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health is seeking a Quality Assurance leader to develop and implement compliant, cost-effective quality systems ensuring products and services meet regulatory standards. The role oversees microbiology lab activities, training, and governance of quality policies to support safe, effective products.

You will manage department operations, supervise staff, and drive continuous improvement in processes.