Biomedical Laboratory Technician (Scientist I)

A Scientist I/Biomedical Laboratory Technician contract-to-hire position is available in Irvine, CA courtesy of Akkodis.

Hour Rate: $27.11/hour (DOE)

Location: Irvine, CA

Type: Contract-to-Hire

Duties:

• Will perform routine and complex testing in compliance with laboratory test methods and procedures to support the stability program, complaint testing, methods transfer and/or methods validation (80-100%).

• As a trainee, the Scientist 1 must have the ability to assimilate and apply information rapidly.

• The Scientist 1 will receive general instructions about required tasks and results expected.

• Work will be well defined and will be 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.

• Perform with confidence, upon training, routine testing in compliance with laboratory test methods and procedures of stability and complaint test samples.

• Develop a competence, upon training, the use of laboratory instruments and equipment.

• Perform daily calibrations/verifications and routine maintenance of laboratory instrumentation and equipment according to current SOPs.

• Work in compliance with current GMPs with regard to documenting, testing and maintaining accurate Laboratory notebooks and data sheets.

• Stability testing of finished goods and complaint analysis is part of this position. Coordination of stability sample pull points, review of stability data, labelling samples, and ensuring timely testing of identified samples in stability protocols.

• Initiate and participate in laboratory investigations of non-conforming laboratory test results.

• Work within a LIMS environment to document test results.

• Collect and prepare laboratory records for evaluation following good documentation practices.

• Ensure personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

• Responsible for communicating business related issues or opportunities to next management level

• Performs other duties assigned as needed.

• Participate in methods validation, instrument qualification and investigations or other work-related duties as assigned by management.

Requirements:

• Experience in a biological laboratory setting.

• Experience following GLP guideline or strict SOP’s.

• Presentation skills and use of Power Point.

• Ability to communicate in a cross-cultural environment.

• Fluent in MS Word and Excel.

Preferred experience:

• A plus: Working knowledge of FDA QSR 21 CFR 820 / ISO13485 quality system requirements and knowledge of both regulatory requirements and other compliance areas.

• Ability to use Laboratory Software Applications such as Chromatographic Data Systems, Laboratory

• Execution Systems and Laboratory Information Management Systems.

• Ability to work independently.

• Must be able to interact well with peers and colleagues. Self-motivated.

• Understand dilution, sterilization, fluent with analytical instruments (GC, HPLC, etc.) or Microbial Identification..