Over de functie
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.
- Management of lab staff direct reports including completion of performance feedback, reviews, disciplinary action and time card 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:
o Sterility Testing per USP <71>
o Endotoxin per USP <85>
o Particulate Matter per USP <788>, <789>, <787>
o Water for Pharmaceutical Purpose <1231>
o Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests <61>
o 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 refrigerator.
- 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.
Maak het verschil
Set Yourself Apart: Profile/Experience
- 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 cGMP/GLP/GDP, USP, FDA regulatory requirements.
Wat bieden wij?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.