KNOWLEDGES SKILLS AND ABILITIES
- Understanding role of quality control/assurance in an organization
- Understanding of medical terminology and laboratory calculations
- Ability to multitask and organize time efficiently
- Must be capable of working with small, delicate pieces of expensive instrumentation
- Must be capable of wearing all protective wear required for entry into the cleanrooms. This includes items such as a sterile mask, gloves, overalls, hairnet, face mask/hood, and shoe covers
- Good communication and writing skills
- Works effectively with others as part of a team
- Aseptic hand hygiene and garbing
- Aseptic technique in a cleanroom and laboratory setting
EDUCATION AND/OR EXPERIENCE
- Cleanroom experience
- Preferred knowledge and experience
- Environmental monitoring experience
- Knowledge of Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
CERTIFICATIONS, LICENSES, AND REGISTRATIONS
PHYSICAL DEMANDS AND WORK ENVIRONMENT
The requirements listed below are representative of the knowledge, skill and / or ability required.
- Majority of time can be spent wearing protective laboratory attire (Examples of attire include: goggles, gloves, cleanroom coveralls, shoe covers, hair net, and face cover)
- Minimal exposure to physical risks, such as operating dangerous equipment or working with chemicals
- Some travel possible but not frequent
- Must be able to stand for long periods of time
- Must be able to wear required safety equipment for long periods of time
JOB TITLE: Environmental Monitoring Technician
FLSA STATUS: Non-Exempt
REPORTS TO: QC Manager
The Environmental Monitoring Technician will be responsible for the setup and execution of environmental and personnel monitoring in support of production operations. The Technician will also be responsible for supporting the microbiological laboratory in daily tasks.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Ability to set-up, maintain and perform various environmental monitoring related activities as required for a cGMP compliant operation according to the applicable guidelines, i.e. FDA, GMP, ICH etc.
- Ability to follow proper gowning practices for cleanroom environments.
- Ability to follow procedures to collect and process environmental monitoring viable and non-viable samples in a controlled manufacturing aseptic and non-aseptic cleanroom environment.
- Perform environmental monitoring for aseptic filling processes.
- Perform personnel monitoring for aseptic gown qualification.
- Properly record all collected EM samples and maintain documentation in adherence to GDP.
- Ability to operate EM equipment such as Particle Counter, Microbial Air Sampler and verify that the equipment is within calibration prior to use.
- Ability to handle all types of media plates used in environmental monitoring.
- Notify QC Manager that the preventative maintenance of laboratory and testing equipment is due.
- Support laboratory in autoclaving cleanroom supplies
- Ensures all work performed strictly adheres to cGMP.
- Ability to work independently as well as in a team atmosphere and work flexible hours to support manufacturing operations.
- Provide technical and administrative support for all activities to environmental monitoring, documentation, and quality auditing.
- All other duties may be assigned as required.