Environmental Monitoring Tech I

Fujifilm•Santa Ana, CA

1d•Onsite

About The Position

This individual will perform tests for monitoring environmental conditions throughout the facility during sterile filling activities and maintain all documentation for traceability. They will perform/support monitoring of the water systems for GMP and maintain all documentation generated from the various monitoring programs for traceability. This position will be working 2nd shift 1pm-9:30pm.

Requirements

High School diploma.
Some college courses in Microbiology preferred.
0-2 year of experience doing environmental monitoring in a cleanroom environment or working in a cleanroom environment.
Knowledge of cGMP and GDP preferred.
Cleanroom experience preferred.
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.
Ability to speak and read English.
Good oral and written communication skills.

Nice To Haves

Degree in Microbiology ideal.

Responsibilities

Provide documentation support of testing and monitoring activities in the QC lab.
Document environmental monitoring of the production rooms.
Monitor and report activities related to the on-line monitoring program.
Perform testing as designated and upon satisfactory training qualification.
Testing on environmental conditions to monitor regulated areas.
Maintain and record data clearly and precisely
In-process testing of liquid media
Receive/Process QC Samples of Finished Liquid/Powder Goods
Provide support to manufacturing for all aseptic validation inspections
Maintain and record the retention of all Finished Goods received in QC
Initiate Environmental Monitoring OOS notification and Investigation.
Provide feedback on observations during the EM