Microbiology Supervisor

Microbiology Supervisor Fagron - 2.6 Wichita, KS Job Details Full-time 14 hours ago Benefits Health savings account Paid holidays Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Qualifications Technical documentation Pharmaceutical regulatory compliance Corrective and preventive actions (CAPA) GMP Laboratory compliance Laboratory techniques Technical writing Sterile laboratory techniques FDA regulations Full Job Description Who We Are Since 1990, we've grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics — we deliver smart, ready-to-use solutions that make healthcare better. We're passionate, science-driven, and always looking for new ways to improve lives. Explore your future at Fagron Career Site. About the Job The Microbiology Supervisor is responsible for overseeing the operations of the microbiology laboratory. Duties include managing direct reports, acting as Subject Matter Expert (SME) and contributing to audit-readiness. Perform routine testing and per review as needed. Key Responsibilities Management of lab staff direct reports including completion of performance feedback, reviews, disciplinary action and timecard administration Ensure testing is initiated and performed in a timely manner and adhering to quality standards Act as laboratory SME Draft protocols and coordinate with laboratory manager to conduct investigations and special studies as needed Draft and edit SOPs as needed Approve CoAs as needed Conduct and/or approve method suitability as needed Adhere to SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations. Perform microbiological testing and method validation related for the following microbiological test methods: Sterility Testing per USP Endotoxin per USP Particulate Matter per USP , , Water for

Pharmaceutical Purpose Microbiological Examination of Nonsterile Products:

Microbial Enumeration Tests Other tests as needed Microbiological growth promotion Adhere to controlled substance requirements Receive, and release media, buffers, and microorganism cultures Update and review microbiological trending Compose, update, and review procedures and training materials Sanitize the laboratory incubators and refrigerators Maintain and coordinate equipment / instrumentation maintenance, calibration, and repair work Clean and sanitize the microbiology laboratory rooms surfaces and equipment Manage personal time off by requesting the time off in company time keeping system for either PTO or VPTO according to company policy for salary employees as well as approving requests for direct reports. See company handbook for policy details. Other duties as assigned Basic Qualifications Bachelor's degree in microbiology, biology, or related scientific field or equivalent experience, graduate degree is a plus Prior management experience preferred Six (6)+ years of experience in a pharmaceutical microbiology laboratory, combined laboratory and pharmaceutical quality experience will be considered (graduate degree may be considered as contribution to experience) Knowledge of c

GMP/GLP/GDP, USP, FDA

regulatory requirements Experience performing microbiological testing / environmental monitoring using aseptic techniques Excellent interpersonal communication and organizational skills Demonstrated leadership skills Qualified to work with controlled substances Experience Handling Biohazardous materials Ability to interpret technical documents Proficiency in technical writing with an emphasis of deviations, CAPAs, etc. Project Management experience a plus Must be comfortable interacting within multiple areas of an organization and be able to communicate technical content in a concise and clear manner What's on Offer? Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off. At Fagron, you'll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine. Ready for the challenge? We're proud to be an equal opportunity employer. Diversity makes us stronger, and we're committed to creating an inclusive workplace where everyone feels welcome. Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

Job Reference:

NA00397