QC Technician Microbiology/Biological Science Job 2022
QC Technician, Microbiology will report to the QC Supervisor, Microbiology or equivalent. This position will conduct routine and non-routine microbiology analysis and environmental monitoring. In addition to, monitoring utilities and maintaining microbiology inventory, etc.
Job Title: Quality Control Technician
Location: Elwood, KS
Basic Minimum Requirements:
- High School Diploma/GED with 5years experience, BA or BS degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or closely related field, or comparable experience.
- Technical skills in microbiology to include, but not limited to aseptic technique, sterile gowning, and pipetting are required.
- Excellent computer, documentation, communication, and organizational skills required.
- Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or
- Completion of Administrative Skills Testing if applicable.
Qualified candidates must be legally authorized to be employed in the United States.
- Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Conduct routine and non-routine Microbiology based analysis of raw materials, in-process materials, finished goods, and stability samples.
- Perform routine and non-routine environmental monitoring (air viable, air non-viable, and surface sampling) of manufacturing environments.
Perform monitoring of utilities to include WFI, USP Water, Pure Steam, and Clean Compressed Air.
- Conduct microbiology testing to include total organic carbon, conductivity, endotoxin, bioburden, growth promotion, mycoplasma, sterility, microbial identifications, gram stains, and personnel sampling.
- Execute gowning qualification personnel performing activities in classified sterile environments.
- Provide production support and participate in production fills and aseptic process simulations.
- Participate in internal assessments and audits as required.
Assist in preparation of Certificates of Analyses, OOS/OOT Investigations, EM and Facility Investigations, and Deviations during testing.
- Assist in developing and qualifying/validating new testing methods and method transfers. Write and revise testing methods.
- Assist in the development of specifications and justification of specifications.
- Assist in preparation of QC standard operating procedures and forms.
- Support equipment validation, calibration, and maintenance.
- Assist in preparation of QC method validation protocols/reports and other analytical study reports.
- Assist in the recommendation of new technologies and methods.
- Maintain QC Microbiology inventory, perform daily temperature checks on necessary equipment, and perform weekly cleaning of laboratory spaces.
Ensure the QC lab is held to cGMP, safety, and environmental standards.
- Generate and report accurate data that meet regulatory compliance.
- Achieve and maintain gown qualification for sterile environments.
- Experience in cGMP environment preferred
- Experience with sterility, mycoplasma, environmental monitoring, and water testing preferred.
- Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, EU as related to QC activities
- Experience related to method development/validation.
- Use of instrument software to obtain results.
Strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.
- Experience with Microsoft Office (Microsoft Word, Excel, PowerPoint, and Outlook)
QC Technician Microbiology