Quality Control ​/Environmental Monitoring Technician

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.

Your 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.
• Develops and Maintains QC Methods:
  Assists in developing, qualifying/validating, and transferring new test methods. Contributes to the writing and revision of testing methods, specifications, SOPs, and validation protocols/reports. Maintains lab inventory and performs routine equipment maintenance and cleaning.

What You Need to Succeed (minimum qualifications):

• Education:
  
  High School Diploma/GED with 5 years experience, BA or BS degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or closely related field, or comparable experience.
• Experience:
  
  Technical skills in Environmental Monitoring 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:

• 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.