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. 101 Job(s) gefunden Zurück 06070809 Vorwärts Customer Service Representative Nazareth Customer Service Fagron België is op zoek naar een enthousiaste en klantgerichte medewerker voor onze klantendienst. Als marktleider in farmaceutische bereidingen streven wij ernaar om de hoogste kwaliteit en service te bieden aan onze klanten. Als lid van ons klantendienstteam speel je een cruciale rol in het verstrekken van ... Global Sourcing Lead Shanghai Procurement We are currently looking for a Global Sourcing Lead. In this position, you will be responsible for Fagron’s global sourcing efforts and you will work closely with our regional teams in Europe, North America, Latin America, China and India to lead centralized direct and indirect sourcing efforts. You will be ... Global Sourcing Lead Shanghai Procurement We are currently looking for a Global Sourcing Lead. In this position, you will be responsible for Fagron’s global sourcing efforts and you will work closely with our regional teams in Europe, North America, Latin America, China and India to lead centralized direct and indirect sourcing efforts. You will be ... Environmental Monitoring Senior Technician - 3rd Shift Wichita Quality Control The Environmental Monitoring (EM) Senior Technician is responsible for training, coordinating, and providing oversight of routine environmental monitoring sampling of classified manufacturing, filling, and support areas for pharmaceutical operations. Responsibilities: · Responsible for ensuring the aseptic ... Sales Manager (m/w/d) Glinde Sales Entwicklung und Umsetzung der Salesstrategie sowie von SaleskonzeptenErstellung von Reports und Analysen über die Kunden-, Markt-, Wirtschafts- und Wettbewerbssituation sowie über TrendsKontinuierliches Controlling und Optimierung des Ertrages innerhalb der TeamsIdentifizierung und Erschließung neuer Absatzpotenziale ... Zurück 06070809 Vorwärts