Sr.Microbiologist - Los Gatos, CA | Biospace
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Apex Life Sciences

Los Gatos, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biochemistry, Biology, Environmental Health & Safety, Lab Technician, Laboratory, Medical Device, Microbiology, Toxicology,

Job Description

Senior Microbiologist

Provides support to the microbiology department in the areas of sterilization program, environmental monitoring, data analysis, problem solving, new product support, and Regulatory compliance.

* Co-ordinate and ensure routine testing including bioburden, LAL, environmental monitoring, sterility and particulate testing are performed according to standard operating procedures.
* Performs departmental procedural updates to be compliant to applicable standards.
* Assists in maintaining FDA compliance standards and other applicable standards, keeping up-to-date on current regulations and industry standards.
* Support new product introductions by performing biological safety testing, including bio-compatibility, sterility assurance, residual analysis, LAL and bioburden testing.
* Provides lab support including LAL testing, lab equipment calibration and maintenance.
* Performs data collection and analysis to monitor trends in test results.
* Interfaces between outside testing laboratories and representatives from other departments, for various biological safety and sterilization test activities
* Co-ordinates Quarterly Dose Audits.
* Writes non-conformance reports & CAPA reports; Co-ordinates with other departments for timely closure of reports.
* Assists with regulatory audits at the site and help assist supplier audits(may be required to travel).


Bachelors in Science/Microbiology; 4-6 years of experience in medical device industry preferably in Microbiology; Experience in Sterilization Validations, Cleanroom Validations, Microbial Investigations and Root cause analysis is preferred.