QC Microbiology Manager
Core
Manage microbiology laboratory systems, environmental monitoring, and product testing to ensure compliance with FDA regulations and company quality policies.
Role type
Senior IC Quality Assurance Manager (Microbiology)
Builds
Reliable, safe, and effective pharmaceutical/medical device products and services
Domain
Pharmaceutical/Medical Device Manufacturing
Required skills
Microbiology, 21 CFR 210/211 compliance, equipment qualification, software validation, test method validation, environmental monitoring, process validation, validation and technology transfer, technical writing, budget management, team leadership
Preferred skills
Advanced degree in Microbiology/Biology, experience with validation reports and execution of laboratory tests
Technologies
Microsoft Word, Microsoft Excel
Responsibilities
Oversee Microbiology laboratory systems and Environmental Monitoring Program; recommend approval/rejection of starting materials, intermediates, and finished products; conduct laboratory investigations of discrepancies and implement corrective/preventive actions; ensure proper laboratory hygiene and storage conditions; train and develop laboratory personnel; manage department operations and budget.
Seniority
Senior, hands-on IC with management responsibilities