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QC Microbiologist

Astrix Technology Group
Irvine, California, US
Closing date
Aug 18, 2022

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Academic / Research
Conservation science
Salary Type
Employment Type
Full time
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Seeking a mid-level *Microbiologist *within our Medical Device Contract Testing Laboratory to join their fast-growing team!

*Position: * QC Microbiologist
*Location: *Irvine, CA
*Direct Hire Opportunity *

*Job Description: *
* Perform microbiological testing utilizing knowledge of USP, AAMI, ISO and other applicable standards or guidelines.
* Prepare or participate in the preparation of test specifications in conjunction with the requirements of the applicable standards and/or client instructions.
* Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per SOPs, and according to applicable work instructions.
* Assure proper records and sufficient data are maintained on all testing and the research information.
* Participate in the improvement of documents, test systems, quality systems and workflow.
* 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.
* 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 is preferred.
* Awareness of applicable guidelines and regulations including, but not limited to USP, ISO, CTFA, FSA.
* Ability to work in GLP/GMP environment.


Job Type: Full-time

Pay: $50,000.00 - $75,000.00 per year

* 401(k)
* Dental insurance
* Health insurance
* Paid time off
* Vision insurance
* 8 hour shift

Ability to commute/relocate:
* Irvine, CA: Reliably commute or planning to relocate before starting work (Required)

* Bachelor's (Preferred)

* Bioburden: 1 year (Preferred)
* Endotoxin: 1 year (Preferred)
* LAL: 1 year (Preferred)

Work Location: One location
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