Performs environmental monitoring sampling of aseptic areas, along with testing needed to support personnel monitoring for production.
• Conducts and analyzes in-process and final product quality analyses/inspection in compliance with standards and regulatory requirements
• Identifies on-going quality issues, prevents potential production issues and makes suggestions for improvement
• Interprets and evaluates analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary
• May be responsible for analytical and protocol report writing and standard operating procedures.
• May be responsible for maintaining lab equipment and reagent preparation and quality.
• Maintain supplies/stocks needed by production team.
• Ensure that lab cleanliness and safety standards are maintained.
• Train other analysts to perform laboratory procedures and assays.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
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