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Miles
Km80.5

Environmental Monitoring/QC Associate

La Jolla Biologics

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Location: San Diego, CA Posted Date: 4/17/2013 Position Type: Full time Job Code: 2013-010 Required Education: Bachelors Degree Areas of Expertise Desired: Analytical Chemistry
Biochemistry
Biology
Chemistry
Laboratory
Quality Control

Description

Summary

Responsible for conducting environmental monitoring of clean rooms and sampling testing of pharmaceutical grade water.  

Job Responsibilities

Essential
?   Perform sampling of non-viable air, viable air, and viable surface samples for manufacturing clean rooms, incubations of samples and reading/interpreting/reporting of results.  
?   Perform gowning qualifications for clean room personnel.
?   Sampling and testing of RODI and WFI water systems.
?   GMP documentation of laboratory testing using forms and logbooks, and summarizing of test results.
?   Contribute to investigations into testing failures, identification of root causes, and implementation of corrective actions.
?   Technical expertise with environmental monitoring equipment.

Requirements

Job Requirements

Education and Experience
?   B.S. Analytical Chemistry, Biochemistry, Chemistry, Biology or related disciplines.  
?   Minimum of 3-4 years of GMP industry experience performing environmental monitoring of cleanrooms and sampling/testing of pharmaceutical grade water systems.

Knowledge, skills and abilities
?   Cleanroom gowning in Class 10,000 and 100,000 environments.
?   Gowning qualifications for Class 100 environments
?   Technical expertise with environmental monitoring equipment.
?   Willingness and ability to communicate and work flexibly is essential.
?   Excellent speaking and documentation skills are required.
?   Ability to multitask in technical responsibilities is desired.
?   Proficient with the following software: Microsoft Word and Excel.  

Work Environment/Physical Demands/Safety Considerations
?   Standard office environment
?   Standard Lab environment
?   Manufacturing clean room environment
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