Perform routine glassware and apparatus preparation, washing and sterilization in compliance with specified Standard Operating Procedures. Schedule and conduct Environmental Monitoring to support manufacturing activities and for product release while following GLP, QO 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.
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.
- Routine glassware and apparatus preparation, washing of glassware
- Decontaminate materials from laboratories via autoclave sterilization
- Sterilize glassware and other materials for use in laboratories
- Pickup and delivery of laboratory equipment and glassware for cleaning and sterilization based on several communication channels and schedules
- Prepare aseptic and non-aseptic media for other groups within QO
- Perform Environmental Monitoring in production areas
- Monitor processes and alert supervisory personnel of known or suspected quality problems
- Practice basic aseptic laboratory procedures as per training and SOPs
- Apply Good Laboratory Practices (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
- Perform sterility testing, water sample testing, moisture analysis and other various biological tests as needed.
- Assist in inventory management of laboratory supplies, assist in the equipment preparation and sterilization for laboratories as needed.
Education and Experience
- Two years associate degree in science or
- One to two years relevant experience with relevant science-based college courses.
- Bachelor’s degree in biological sciences/chemistry
- Experience with aseptic manufacturing environments
- Competent using Window-based applications, specifically MODA, SAP, LIMS, Process Runner and Excel
Technical Skills and Competencies
Basic Aseptic technique, Excellent Organization, Verbal and Written Communication skills, Experience in dishwasher and autoclave operation beneficial.
Basic understanding of aseptic operation and microbiology.
Experience with aseptic practices and aseptic manufacturing areas, Knowledge of MODA SAP, LIMS, Process Runner and Microsoft Excel.
Physical Position Requirements
- Ability to lift 20-50 pounds routinely, withstand long periods of standing, exposure to temperature. Manual dexterity using hands and fingers
- Withstand long periods of standing
- Exposure to high temperatures (autoclaves)Occasional need to sit, reach with hands and arms
- Manual dexterity using hands and fingers
- Specific vision abilities required by this job include close vision work
- Occasional need to sit, reach with hands and arms
- Ability to work flexible hours, work weekend and overtime