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, particulate matter testing via the use of a laser particle analyzer or microscopic examination, endotoxin testing, 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 medical devices 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 Bioburden, Limulus amoebocyte lysate (LAL) Sterility for Medical Devices, Off-Site Clean Room Validation and Monitoring, 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.
- Perform onsite and offsite testing.
- 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.
- Driving a company car for offsite work, if applicable.
- Other duties as assigned.