Senior Microbiology QA Manager

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

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

HSA (Health Savings Account)

Paid time off

Job summary

Cardinal Health is seeking a Quality Assurance professional to oversee microbiology lab systems, environmental monitoring, and material approvals to ensure compliance with applicable regulations. The role emphasizes collaboration with validation and maintenance teams and ongoing process improvements.

The ideal candidate has a strong background in microbiology, extensive experience in FDA-regulated environments, and proven documentation and writing skills to support quality programs and audits.

Qualifications

• B.S. degree in Microbiology, Biology, or related science field. Advanced degree preferred.
• At least 7-10 years of relevant work experience in FDA-regulated industry (Pharmaceutical or Medical Device).
• Must have experience with equipment qualification, software validation, test method validation, environmental monitoring, and/or process validation.
• Must understand Validation and Technology Transfer process and have experience with writing procedures/reports and execution of laboratory tests.
• Must work well with others and succeed in a team environment.
• Must be detail oriented, organized, multitask, a self-starter and self-motivated.
• Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.

Responsibilities

• Oversees the Microbiology laboratory systems to ensure data generated comply with regulations and policies.
• Maintains Environmental Monitoring Program as required.
• Recommends approval or rejection of starting materials, intermediates, and finished products.
• Collaborates with validation team and maintenance regarding lab equipment conformance.
• Inspects, investigates and samples to monitor factors affecting product quality.
• Ensures all testing is carried out and records are evaluated.

Skills

Technical writing

Education

B.S. degree in Microbiology, Biology, or related science field

Advanced degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health is seeking a Quality Assurance professional to oversee microbiology lab systems, environmental monitoring, and material approvals to ensure compliance with applicable regulations. The role emphasizes collaboration with validation and maintenance teams and ongoing process improvements.

The ideal candidate has a strong background in microbiology, extensive experience in FDA-regulated environments, and proven documentation and writing skills to support quality programs and audits.