|
Biology
Lab Technician - Irvine, CA
Edwards Lifesciences
Job
details
Job Type
Full-time
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.
QUALIFICATIONS
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.
|
