Quality Control /Environmental Monitoring Technician

Responsibilities

• Conducts Environmental Monitoring: Performs routine and non-routine sampling of manufacturing environments (air and surfaces) and utilities (WFI, USP Water, Pure Steam, Clean Compressed Air). Maintains gowning qualifications for sterile environments.
• Ensures cGMP Compliance: Upholds cGMP, safety, and environmental standards within the QC lab, generating accurate and compliant data. Participates in internal assessments and audits.
• Performs Microbiological Testing: Executes routine and non-routine analyses of raw materials, in-process materials, finished goods, and stability samples. Conducts a variety of microbiology tests, including bioburden, sterility, and microbial identifications.
• Supports Investigations and Deviations: Assists in the investigation of out-of-specification/out-of-trend results, environmental monitoring excursions, and deviations. Contributes to the preparation of Certificates of Analysis.
• What You Need to Succeed (minimum qualifications):
• Education : High School Diploma/GED with 5years experience, BA or BS degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or closely related field, or comparable experience.
• Experience : Technical skills in Environmental M onitoring to include, but not limited to , monitoring of manufacturing environment and utilities.
• Excellent computer, documentation, communication, and organizational skills required .
• What will give you a competitive edge (preferred qualifications):
• Experience in cGMP environment preferred
• Experience with environmental monitoring, water testing , sterility, and mycoplasma preferred.
• Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, EU as related to QC activities
• Experience related to method development/validation.
• Strong attention to detail, strong problem-solving skills, as well as, the ability to work in a cross-functional team environment.
• Elanco Benefits and Perks :
• We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Benefits

Additional Information

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Quality Control /Environmental Monitoring Technician Environmental Monitoring / QC Technician Microbiology will report to the QC Supervisor, Microbiology or equivalent. This position will conduct routine and non-routine environmental monitoring of the manufacturing facilities and associated utilities , as well as microbiology analysis.

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