Perform sterility testing, including Sterility Dose Audits (SDAs) and Biological Indicator (BI) testing, maintaining a sterile field. 5 years of relevant experience in a Sterility Assurance Microbiology Laboratory setting.
Numbers & Facts
Location
San Diego, CA
Salary
$32.50 Per Hour
Description
Location: San Diego, CA
Duration: 12 Months
Work Mode: Onsite
Hours: Monday to Friday, 6:30 am start or later is preferred
Responsibilities:
Perform sterility testing, including Sterility Dose Audits (SDAs) and Biological Indicator (BI) testing, maintaining a sterile field.
Conduct non-sterile bioburden testing and particulate testing.
Execute LAL testing and associated validations/revalidations.
Support training and testing, ensuring turnaround times are met.
Monitor the environment of the laboratory, controlled areas, and lab spaces as applicable.
Prepare media for testing, conduct quality checks, and sterilize testing equipment.
Gather and trend test data metrics.
Review Quality Management System (QMS) documents and procedures prior to release or update as required.
Identify compliance issues proactively and verify alignment with internal and external standards and policies.
Notify and collaborate with functional management when Out of Specification (OOS) occurs.
Maintain a positive and cooperative team dynamic.
Assist in the design and implementation of new laboratory equipment.
Support training initiatives and training of new associates.
Requirements:
Minimum of a Bachelor's degree in science (Microbiology or Biology related).
5 years of relevant experience in a Sterility Assurance Microbiology Laboratory setting.
Understanding of ISO 13485, 21 CFR 820, and other related standards.