Environment Monitoring Tech II

Responsibilities

• Provide documentation support of testing and monitoring activities in the QC lab. Includes but not limited to Clean Room and Water System data.
• Maintain and record data clearly and precisely
• Document environmental monitoring of the production rooms
• Report activities related to the on-line monitoring program
• Perform testing as designated
• Perform Sterility testing on the Finished Liquid products, as necessary
• Identify and related testing in conjunction with microbial contamination
• Maintain an organism library while documenting and archiving new organisms found in clean rooms
• Provide training to new hires or Mfg. personnel assigned to QC EM tasks for support
• Support equipment validations for equipment related to EM
• In-process testing of liquid media as necessary
• Support production and manufacturing activities as needed as a quality representative
• Other duties as necessary

Requirements

• High School diploma
• Some college courses in Microbiology preferred
• Degree in Microbiology ideal
• 2-3 years 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

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• 401k
• Paid Time Off