Scientist I

Location: Irvine, CA

Shift: Sunday - Thursday OR Tuesday - Saturday

The Scientist Level 1 will report directly to the Laboratory Lead/Manager and after training will perform routine testing in compliance with laboratory test methods and procedures to support the manufacturing and timely delivery of product to customers (80 to 100%). As a trainee, the Scientist 1 must have the ability to assimilate and apply information rapidly. The Scientist I will receive general instructions about required tasks and results expected. Work will be well defined and is reviewed for accuracy upon completion. The Scientist 1 is expected to apply standard practices and techniques in specific situations and to recognize discrepancies in results and follow operations through a series of detailed steps and processes. Additionally, the Scientist Level 1 has accountability and ownership to maintain laboratory instruments in their qualified state.

Responsibilities:

• Performing with competence, upon training, routine testing following laboratory test methods and procedures.
• Developing a competence, upon training, in the use of laboratory instruments and equipment.
• Performing daily calibrations/verifications and routine maintenance of laboratory instrumentation and equipment according to current SOPs.
• Working in compliance with current GMPs with regard to documenting, testing and maintaining accurate laboratory notebooks and data sheets.
• Raw material, In-process and finished goods testing when thorough training has been completed. Initiation and participation in laboratory investigations of non-conforming laboratory test results.
• Collecting and preparing laboratory records for evaluation following good documentation practices.
• Ensuring personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

Qualifications:

Required

• Bachelor's Degree in a scientific discipline. such as Microbiology, Biology, or a closely related field
• 0-2 years in laboratory or related environment
• Strong understanding of compliance with applicable laboratory and safety procedure
• Must be self-driven, have strong critical thinking and problem-solving skills, and capable of working independently or in a team.
• Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment

Preferred

• Knowledge of sterilization, disinfection and cleaning technologies for reprocessing of medical devices is strongly preferred
• Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines
• Working experience with sterilants and disinfectants
• Working knowledge of designs and features of medical devices