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Biology Lab Technician - Irvine, CA

Edwards Lifesciences

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Full Job Description

The Biology Quality Laboratory provides a comprehensive range of safety and biocompatibility testing for the evaluation of Edwards medical devices. We are looking for a Laboratory Technician who enjoys being hands on, working in a fast-paced environment, who will take an active role in pre-clinical testing to support Edwards manufacturing, new product development, and submission to FDA and other regulatory agencies.

Primary Responsibilities:

  • Perform and/or assist in biology laboratory testing and processes in in vitro area. The tests include but are not limited cytotoxicity, hemolysis, partial thromboplastin time (PTT), complement activation, and genotoxicity assays.
  • Prepare test samples (products/materials/components) for routine and qualification testing. Perform the cultivation and maintenance of cell/bacterial cultures as required for any in vitro testing.
  • Collect and organize study data files and records.
  • Maintains instruments and pieces of equipment in accordance with manufacturers’ or in-house preventative maintenance and calibration/validation procedures.
  • Maintains laboratory in a safe, clean, and orderly condition, which includes functional checks on laboratory equipment (CO2 incubators, refrigerator/freezer, chart recorders, etc.) and facilitates the storage, collection and disposal of biohazardous or hazardous materials and adheres to regulations relating to health and safety.
  • Manage the laboratory’s inventory for glassware, chemicals, reagents and other supplies by ordering, receiving and storing.


Education and Minimum Requirements:
Associates degree in biology or related scientific field and at least 1 year of relevant in-vitro testing experience in the academic or industry setting (medical device/pharmaceutical/biotech).

Preferred Qualifications:

  • Bachelors degree in Biology or related scientific field
  • One year minimum of hands on experience with in-vitro testing within the medical device industry
  • An understanding of ISO 10993 testing requirements with hands on testing experience in biocompatibility test methodologies

Additional Talents and General Expectations:

·       Ability to work independently .

·       Basic written and verbal communication, interpersonal, and relationship building skills

  • Basic computer skills, including usage of MS Office; experience with electronic equipment systems preferred
  • Able to read, comprehend, write and speak English
  • Moderate knowledge of laboratory processes
  • Moderate knowledge of AALAS (American Association for Laboratory Animal Science) regulations
  • Moderate knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
  • Basic knowledge with ISO/USP/ASTM biocompatibility evaluation requirements
  • Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to biological assays
  • Strict attention to detail
  • Knowledge of GLP (Good Laboratory Practices), GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices) supporting a medical device environment
  • Must be able to work in a team environment and with close supervision
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.



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