FUJIFILM

Stability Project Coordinator

Job Locations US-CA-Santa Ana
Posted Date 3 weeks ago(4/19/2021 4:25 PM)
Requisition ID
2021-14874
Category
Quality Control
Company (Portal Searching)
FUJIFILM Irvine Scientific

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 a Stability Project Coordinator for our Quality Control group. The Stability Project Coordinator will provide stability program administration support for stability studies. Activities include sampling, study management, documentation, and data management.

 

**

External US

Responsibilities:

  • Review and update stability protocols upon revisions to specifications, or regulatory testing requirements
  • Initiate stability studies, data entry, labeling samples, and placing samples in stability chamber
  • Pull samples from stability chambers at appropriate time points
  • Track and receive incoming stability samples and submit for testing
  • Manage stability study files and coordination of testing with project management
  • Clean and organize stability chambers
  • Determine space availability within chamber for incoming studies
  • Accurately document all activities adhering to cGMP and company standards
  • Alert Quality management of any out of trend or out of specification data immediately upon discovery

Experience/ Education:

  • BS/BA in Microbiology or Biology; advanced study in Microbiology is highly desirable
  • 2 or more years of stability planning experience
  • Good skills in tissue culture, biochemical and microbiological testing methodologies
  • Demonstrated supervisory skills
  • Detailed understanding of 21CFR211 – cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material specifications, and related areas
  • Ability to speak, read, and write English well

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed