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Skills
Asepsisunmatched
Autoclaveunmatched
Biologyunmatched
Cell Culturesunmatched
Cleanroomunmatched
Clinical Supportunmatched
Communication Skillsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Environmental Monitoringunmatched
GMP (Good Manufacturing Practices)unmatched
High School Diplomaunmatched
Laboratoryunmatched
Manufacturingunmatched
Manufacturing/Industrial Processesunmatched
Medical Productsunmatched
Presentation/Verbal Skillsunmatched
Production Supportunmatched
Production Systemsunmatched
Quality Controlunmatched
Team Playerunmatched
Writing Skillsunmatched
Description
Job Description:
The Environmental Monitoring (EM) Core Technician will be responsible for conducting EM tasks in support of production and aseptic processing of clinical grade products. The core tech will also be responsible for maintaining, stocking, and set-up of clean room environment.
Responsibilities:
Participates in the Environmental Monitoring process as part of GMP production of viral therapies
Cell culture and product purification using aseptic technique when required
Coordinates EM equipment needs with QC EM team for Manufacturing processes
Drafting, completion and revision of manufacturing documents including Batch Records and EM forms
Buffer and component preparation including operation of steam autoclave
Operation of manual, semi-automated and automated equipment in support of routine clinical production
Operating Environmental monitoring equipment such as Solairs, ApexZ50, active counters
Requirements:
Aseptic technique and experience in cell culture and serological methods preferred
Able to pass Class 10,000 gowning qualification
Computer software skills including Microsoft Office, organization skills, recordkeeping skills, ability to manage multiple projects, time management skills.
Written and oral communication skills, team oriented, independent work skills, strong work ethic
1-3 Years Experience
Basic Lab experience with a Bachelor's degree or Intermediate Lab experience within a cGMP clinical production environment and a High School Diploma.