Liquid Prep Technician - 1st Shift

Fujifilm•Santa Ana, CA

1d•Onsite

About The Position

We are hiring a Liquid Prep Technician. The Liquid Prep Technician will be responsible for controlled room disinfection/prep and set up, assist with Product Inspection, Labeling, Case Packaging, Accountability and Quarantine of Sterile Filled Product. 1st shift: 5am-1:30pm

Requirements

High School diploma
Good work history (previous pharmaceutical or med device experience preferred).
1-2 years of working in controlled/regulated environment experience
General education
Working knowledge of metric system
Good understanding of Good Manufacturing Practices (GMPs)
Ability to speak, read, and write English.
Good oral and written communication skills.

Nice To Haves

Spanish language fluency preferred but not required

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.
Ability to navigate through electronic documentation system.
Responsible for transactions associated with components and supplies used for batch; to maintain inventory accuracy.
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.
Keeps work area, utensils, tanks, mills, and equipment clean and organized per 6S
Ensures that supplies needed such as weigh boats, gloves, lab coats, etc. are well stocked in their designated areas.
Informs 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.