Über die Tätigkeit A microbiologist is responsible for supporting plant-wide remediation activities and continuous improvement efforts with a focus on method development and validation. Plan and execute projects aimed at improving the compliance profile as well as function as Subject Matter Expert, contributing to audit-readiness. Perform routine testing and per review 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 USPAntimicrobial Effectiveness Testing (AET) per USP < 51>Endotoxin per USPParticulate Matter per USP ,Water for Pharmaceutical PurposeMicrobiological growth promotionExperience with Disinfectant Efficacy Testing a plusAdhere to controlled substance requirementsReceive, and release media, buffers, and microorganism culturesUpdate and review microbiological trendingCompose, update, and review procedures and training materialsReview / record daily temperature readingsSanitize the laboratory incubators and refrigeratorsReview media, material, and supply inventoriesMaintain and coordinate equipment / instrumentation maintenance, calibration, and repair workClean and sanitize the microbiology laboratory rooms surfaces and equipmentManage 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. See company handbook for policy details. Ihr Profil Bachelor’s degree in microbiology, biology, or related scientific field or equivalent experienceTwo (2) to Four (4) years of experience in a pharmaceutical microbiology laboratory*Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements* *Experience performing microbiological testing / environmental monitoring using aseptic techniques* *Excellent interpersonal communication and organizational skills* *Qualified to work with controlled substances* *Knowledge and experience performing serial dilutions* *Experience Handling Biohazardous materials*Ability to interpret technical documentsProficiency in technical writing with an emphasis of deviations, CAPAs, etc.Project Management experience a plusMust be comfortable interacting within multiple areas of an organization and be able to communicate technical content in a concise and clear manner Unser Angebot Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents. 88 Job(s) gefunden Zurück 02030405 Vorwärts Aseptic Cleanroom Technician - 2nd Shift Wichita Compounding The Aseptic Technician will assemble finished sterile products with a focus on patient safety and quality; ensures that the clean room remains in a state of constant cleanliness and that supplies are appropriately stacked.Responsibilities:Maintains a sterile environment in the cleanroom, by garbing, cleaning the room, ... Distribution Coordinator Wichita Supply Chain & Logistics Position Summary: The Distribution Coordinator is responsible for performing the day-to-day operations in the warehouse to include processing of all incoming shipments, storage and fulfilment of outgoing shipments to customers. Other duties include but not limited to, picking, packing and sanitation. Key ... Digital Marketing Manager Austin Marketing Are you ready to take your career to the next level and be a key contributor to the revitalization of Fagron’s position in North America? Fagron Brands and Essentials North America, the second largest distributor of high-quality solutions to compounding pharmacies, is searching for a innovative and savvy Digital ... Manufacturing Quality Assistant - 3rd Shift Wichita Quality Assurance Summary:Work with Quality Assurance as a Manufacturing Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. Serve as on the floor presence for line clearances, visual inspection performance, investigation support, deviation/CAPA closure. Every day may be different with changing ... QA Document Control Admin & Trainer Decatur AL Quality Assurance The Document Control Admin & Trainer is responsible for maintaining organized and updated GMP-related documents. Their duties include using document management software to upload or scan paper documents, retrieving documents for authorized personnel and ensuring document storage to comply with in-house procedures and ... Zurück 02030405 Vorwärts