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Schedule and conduct Environmental Monitoring to support manufacturing activities and for product release while following GLP (Good Laboratory Practices), QO (Quality Organization) and Regulatory procedures. Prepare media for Quality Control testing to support manufacturing activities and for product release while following batch records, QO, and GLP procedures. Perform sterility testing, water sample testing, moisture analysis and other various biological tests as needed. Perform routine glassware and apparatus preparation, washing and sterilization in compliance with specified Standard Operating Procedure.
Under close supervision, the Laboratory Technician will perform routine laboratory procedures using aseptic technique, in compliance with specifications in all Standard Operating Procedures and Standard Test Procedures used to support testing and release of product.
" Decontaminate materials from laboratories via autoclave sterilization
" Sterilize glassware and other materials for use in laboratories
" Routine glassware and apparatus preparation, washing of glassware
" Create work orders for equipment when issues arise
" Pick up and delivery of laboratory equipment and glassware for cleaning and sterilization based on several communication channels and schedules.
" Monitor processes and alert supervisory personnel of known or suspected quality problems
" Practice basic aseptic laboratory procedures as per training and SOPs (Standard Operating Procedures)
" Apply (GLP) and Good Manufacturing Practices (GMP) to assigned work
" Learn and demonstrate understanding of basic sterilization principles
" Learn and comply with regulatory requirements such as USDA, FDA, EU
" Assist in inventory management of laboratory supplies, assist in the equipment preparation and sterilization for laboratories as needed.
" Support of the Environmental Monitoring team primarily by reading agar plates and Non-Viable Particle Count (NVPC) totals.
Education and Experience:
Required
" High School Diploma
" One to two years relevant experience.
Preferred
" Associate's degree in biological sciences/chemistry
" Experience with aseptic manufacturing environments
" Competent using Window-based applications, specifically MODA, SAP, and Excel
Date Posted: 01 May 2024
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