Performs viable and non-viable environmental monitoring, water sampling and testing.
Performs sampling, testing, and identification of microbiology samples.
Performs microbiological testing on a range of samples, including chemical raw materials, components (including packaging materials), finished products, water, and environmental samples.
Performs or leads project work, including tech transfers, method and equipment/software validations.
Authors, reviews, or approves supporting documentation relevant to the laboratory (ie... SOPs, training documents, CAPAs, OOS and deviation investigations, change controls, etc).
Serves as a SME and technical leader in the laboratory, laboratory equipment, processes, software, or systems, troubleshooting roadblocks, and training other employees as needed.
Serves on global teams and forums, functioning as a SME for global systems as appropriate.
Enter, process, and review data in various software programs (ie... LIMS, Empower, SAP, etc).
Reviews and approves QC data, while monitoring for trends and abnormalities. Reports, and acts on data results.
Serves as the main point of contact for testing, contract services, and special testing requests including PET investigations and validations.
Performs general maintenance/preventative maintenance/calibration activities when appropriate.
Demonstrates excellent interpersonal communication with personnel inside and outside of QC.
Provides and follows up on ideas for continuous improvements in laboratory processes.
Serves as a subject matter expert in all aspects of the microbiology program during audits and inspections.
Performs tasks typically assigned to the Senior QC Technician role as needed.
Possess knowledge of laboratory equipment and QC/QA process or system
1-year GMP or GLP experience
Bachelor's degree in microbiology or closely related field
2 or more years of microbiology laboratory or related experience
Possess knowledge of laboratory equipment and QC/QA process or system.
2 years of GMP or GLP experience
Project Management experience
Master's degree in microbiology or closely related field