Lab Technician

Summary:

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.

Preferred Skills:

• Team Player
• Quick Learner
• Excellent Communicator