Microbiologist

Candidates in this role are responsible for the accurate and efficient execution of microbiological tests including aseptic processing of sterility tests in a cleanroom suite, endotoxin testing, Microbial Limits Testing, Antibiotic Assay, or other microbiology pharmaceutical testing in accordance with established procedures. Candidates Will collect and present data in a well-reasoned and accurate manner and maintain the laboratory environment according to cGMP guidelines.

Responsibilities:

•    Preparing and performing microbiological tests on cosmetics and pharmaceuticals as recommended by current USP, FDA, and AAMI/ISO regulations.
•    Routine Quality Control of laboratory equipment, media, and microorganisms.
•    Provide accurate test results to customers on a timely basis including but not limited to Microbial Limits Testing, Limulus amoebocyte lysate (LAL), Sterility, etc.
•    Record test results accurately and legibly on all documents.
•    Technical report writing including text, tables, graphs, and diagrams.
•    Assist in the training of new Laboratory Technicians.
•    Follow and perform process qualifications and validations for procedures and/or equipment.
•    Maintain control of test samples including logging in, storage, tracking, and disposal.
•    Monitor test status and conditions as described in Work Instructions and Operating Procedures.
•    Routine maintenance of laboratory environment to include cleaning and troubleshooting.
•    Report any deviations and/or nonconformities to Management.
•    Suggest possible preventative and corrective measures to prevent future deviations and nonconformities.
•    Inventory of laboratory supplies to maintain par levels.
•    Gowning and garbing for cleanroom settings.
•    In cooperation with the Laboratory Manager, responsible for the qualification, maintenance, and calibration of critical equipment.
•    Update procedures for improvement to methods.
•    Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues.
•    Other duties as assigned.