Role involves supporting activities within the Microbiology Lab
Mon - Fri 6:30am start or later is preferred
Responsibilities:
Responsible for sterility testing (SDAs and BI, if applicable), non-sterile bioburden testing and particulate testing while maintaining a sterile field
Responsible for LAL testing and associated validations/revalidations
Responsible for supporting training and testing and ensuring turnaround times are met
Environmental monitoring of the laboratory, controlled areas, and lab spaces as applicable
Preparing media for testing, quality checks, and sterilization of testing equipment
Metrics, gathering and trending of test data
Review QMS documents and procedures prior to release or update as required
Proactively identify compliance issues and verify alignment with internal and external standards and policies
Notify and work closely with functional management when OOS occurs
Maintain a positive and cooperative team dynamic
May assist in the design and implementation of new laboratory equipment
Other duties as assigned
Support training initiatives and training of new associates
Requirements:
Typically requires a minimum of a Bachelor's degree in science (Microbiology or Biology related) with 5 years relevant experience in a related discipline
Understanding of ISO 13485, 21 CFR 820 and other related standards
Numbers & Facts
Location
San Diego, CA
Salary
$35 Per Hour
Skills
Biologyunmatched
Business Intelligenceunmatched
Code of Federal Regulationsunmatched
Environmental Monitoringunmatched
Groundskeepingunmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Laboratoryunmatched
Laboratory Equipmentunmatched
Laboratory Managementunmatched
Maintain Complianceunmatched
Metricsunmatched
Microbiologyunmatched
Sterilizationunmatched
Test Dataunmatched
Test Equipmentunmatched
Trend Analysisunmatched
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