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QC Microbiologist I job in Santa Ana at FISI - FUJIFILM Irvine Scientific

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QC Microbiologist I at FISI - FUJIFILM Irvine Scientific

QC Microbiologist I

FISI - FUJIFILM Irvine Scientific Santa Ana, CA Full Time
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Overview

FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.

We are hiring Quality Control Microbiologists for our first and second shifts. The Quality Control Microbiologist will perform applicable testing on raw, in-process, and final products to insure material quality as well as to perform tests for monitoring environmental conditions and water quality. In addition, this person will perform designated testing, monitoring, calibration, and maintenance of lab equipment in conjunction with approved procedures and test methodologies.

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Responsibilities:

  • Test raw, in-process and finished product
  • Test environmental conditions to monitor regulated areas
  • Test the water systems to ensure water quality is maintained
  • Calibrate and maintain instrumentation and methods as necessary
  • Test material to investigate customer difficulties
  • Maintain and record data clearly and precisely
  • Modify standard operating procedures as necessary
  • Perform identification and related testing in conjunction with microbial contamination 

Experience/ Education:

  • BS/BA degree in Microbiology; advanced study in Microbiology is highly desirable
  • One year in medical device, pharmaceutical, or biotech lab environments
  • Good lab safety
  • Basic understanding of 21CFR211 – cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material specifications, and related areas
  • Good oral and written communication skills

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

 

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Medical Device Directive
Testing
Pharmaceuticals
Biotechnology
Maintenance
Iso 13485

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