Liquid Prep Tech in Santa Ana, California | Careers at Santa Ana, CA


Requisition ID 2021-15490
Category Manufacturing
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 Liquid Prep Technician. The Liquid Prep Technician will perform controlled room disinfection/prep and set up, assist with Product Inspection, Labeling, Case Packaging, Accountability and Quarantine of Sterile Filled Product. In addition, this person will perform inspection and label application for all filled product, case packaging of all sterile filled products into appropriate boxes, bottle/vial preparation and staging.

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External US

Responsibilities:

  • Perform disinfection of controlled (cleanroom, formulation areas), controlled not certified (CNC) and support environments in compliance with SOP
  • Stock requirements such as PPE, equipment and tooling required for production use
  • Reconcile supplies to ensure no interruption to the production floor
  • Stock gown rooms and locker rooms to ensure gowning materials are available for use
  • Support the set-up of clean rooms for filling process; set up workstations and prep incoming materials to manufacture finished goods
  • Support autoclave and disinfection prep for equipment and tooling required to support build and daily/routine cleaning
  • Support cleaning of vessels/tanks used in manufacturing and submit samples for release by quality
  • Ensure all lot folder controlled documents are being followed and appropriately documented as per Good Documentation Practices
  • Follow line clearance requirements to maintain cGMP and cGLP in all work areas
  • Maintain adequate component supplies; keep work area, utensils, tanks, mills, and equipment clean and organized per 6S
  • Ensure that supplies needed such as weigh boats, gloves, lab coats, etc. are well stocked in their designated areas; inform Lead/Supervisor if supplies need to be ordered
  • Follows all safety procedures and works in a safe manner including wearing all required personal protective equipment
  • Monitor production equipment performance, report breakdown, record downtime and ensure proper equipment performance after repair(s)
  • Maintain daily production (Finished Good Transfer, Drum Lift Checklist) and housekeeping logs
  • Ensure all safety procedures are being followed
  • Ensure all company quality and regulatory guidelines, standards, and practices are adhered to
  • Guide all production activities toward company key performance indicators (KPI) expectations
  • Other duties as assigned by supervisor

Experience/ Education:

  • High School Diploma or equivalent required
  • Good work history (previous pharmaceutical or med device experience preferred)
  • 1-2 years of working in controlled environment experience
  • Working knowledge of metric system
  • Good understanding of Good Manufacturing Practices (GMPs)
  • Ability to speak, read, and write English
  • Spanish language fluency preferred but not required
  • 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.

Posted
10/02/2021
Salary Range
$46,000.00 - 72,000.00
per Year
Salary range estimated by
Location
Santa Ana, CA 92701, US
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