Lab Technician

Cynet Systems•San Diego, CA

About The Position

Reporting to the Microbiology Lab Supervisor, the Sr. QC Technician supports activities within the Microbiology Lab. The role performs studies and microbiology testing according to established work instructions, procedures, protocols, and standards. It requires accuracy and attention to detail, accurate recordkeeping, and compliance with internal Quality Assurance procedures and external standards and regulations. The technician prepares for and performs scheduled tests, including sterility assurance and microbiology testing, while maintaining a sterile field. The role also supports training, test turnaround times, environmental monitoring, media preparation, test-data metrics and trending, and review of QMS documents and procedures. The position may assist with the design and implementation of new laboratory equipment and perform other duties as assigned.

Requirements

Typically requires a Bachelor's degree in a science field related to Microbiology or Biology.
Five or more years of relevant experience in a related discipline.
Understanding of ISO 13485, 21 CFR 820, and other related standards.
Experience in a Sterility Assurance Microbiology Laboratory setting, including testing such as bioburden and sterility dose audits.
Knowledge of sterile technique and bacterial endotoxins testing.
Accuracy, attention to detail, and accurate recordkeeping.
Team player, quick learner, and excellent communicator.

Nice To Haves

A work start time of 6:30 a.m. or later is preferred to allow more overlap with the rest of the team.

Responsibilities

Perform sterility testing, including Sterility Dose Audits (SDAs) and biological indicator (BI) testing, if applicable; perform non-sterile bioburden and particulate testing while maintaining a sterile field.
Perform LAL testing and associated validations and revalidations.
Support training and testing, and ensure turnaround times are met.
Conduct environmental monitoring of the laboratory, controlled areas, and lab spaces as applicable.
Prepare media for testing, perform quality checks, and sterilize testing equipment.
Gather and trend test data and metrics.
Review QMS documents and procedures before release or updates as required.
Proactively identify compliance issues and verify alignment with internal and external standards and policies.
Notify and work closely with functional management when an out-of-specification (OOS) result occurs.
Maintain a positive and cooperative team dynamic.
May assist in designing and implementing new laboratory equipment.
Support training initiatives and train new associates.
Perform other duties as assigned.