Laboratory Technician II

Imperative Care•Campbell, CA

1d•$31 - $36•Onsite

About The Position

This experienced Laboratory Technician provides microbiology and endotoxin testing support in a clinical setting for the development, manufacture, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives.

Requirements

A minimum of 2 years of laboratory experience in the medical device industry; or equivalent combination of education/training and work experience; or equivalent combination of education and work experience.
Experience in Endotoxin testing and Environmental monitoring program is required.
Proficiency in clinical lab protocols and safe handling procedures for hazardous chemicals.
Must be knowledgeable about quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001) and good manufacturing practices.
Strong communications skills (both written and verbal)

Nice To Haves

Associates, or bachelor’s degree in Science, Microbiology or related discipline preferred.

Responsibilities

Prepare and analyze microbiological samples (air, water and Product) for endotoxin, fungi and bacteria.
Sample collection, receipt, log in and data entry in a timely and accurate manner.
Deliver and transport samples as required.
Complete sample preparation and routine analysis.
Perform viable and non-viable environmental monitoring in controlled environments and compressed air monitoring.
Monitor and maintain accuracy of lab inventory and record keeping.
Prepare reagents and standards for analysis.
Follow SOPs, WIs, Lab safety and quality requirements.
Assist in the execution of complex method development and method validation activities.
Participate in equipment validations, and support change orders as required.
Remain current on all training and foster a safe working environment.
Understand and follow safe handling procedures for hazardous chemicals.
Work collaboratively with team members on analyses as required.
Communicate internally with the team, other departments as required.
Contribute to lab continuous improvement efforts on improved methods and method development.
Maintain 6S in the laboratory and general laboratory housekeeping.
Comply with established Quality Systems and report quality deficiencies.
Support the non-conforming materials program, and complaint investigations.
Collaborate with team members to define validation requirements, specifications, testing, and component/product acceptance activities, author and route validation protocols and reports.