Microbiologist (Custom Project)
- Location: Irvine
- Type: Direct Hire
- Job #34979
Medical Device Contract Testing Laboratory is seeking a mid-level Microbiologist to join their fast-growing team!
Shift: Monday-Friday, 1st shift. May required weekends & OT
- Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per SOPs, and according to applicable work instructions. May be requested to conduct more involved studies.
- Participate in analyzing and interpreting results. Assure proper records and sufficient data are maintained on all testing and the research information is presented in a logical methodical comprehensive conclusive and scientifically sound manner.
- Perform microbiological testing utilizing knowledge of USP, AAMI, ISO and other applicable standards or guidelines.
- Communicate test schedule updates to management as needed.
- Participate in the improvement of documents, test systems, quality systems and workflow.
- Procure and maintain all test equipment and supplies used for microbiology testing.
- Prepare or participate in the preparation of test specifications in conjunction with the requirements of the applicable standards and/or client instructions.
- Direct client contact as needed.
- Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and for taking all concerns to management as required.
- Accurately collects and records raw data in logbooks and on worksheets.
- Maintain relevant supplies, materials, and equipment used in routine testing.
- Assure testing/test article preparation/product is performed within due dates.
- Prepare and maintain cell lines and reagents and/or test articles as required and applicable for testing.
- Routes all positive results or unusual testing occurrences to management.
- Responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
- Perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable.
- Operate autoclave, depyrogenation oven or other specified laboratory equipment as applicable.
- Perform Kinetic-Chromogenic LAL testing as applicable.
- Perform Environmental Monitoring, clean and disinfect cleanroom suites as applicable.
- Other duties as assigned.
- Bachelor degree and 4 years of experience; or high school diploma and 10 years of applicable experience.
- Sound judgment with effective decision making skills and the ability to solve problems or escalate as needed
- Awareness of applicable guidelines and regulations including, but not limited to USP, ISO, CTFA, FSA.
- Ability to work in GLP/GMP environment.