The main function is to provide testing services in a laboratory environment.
Job Responsibilities: • Perform routine testing services using established procedures/protocols (e.g sterility, bioburden, aseptic filtration, environmental collection and testing, receive, inspect, in process solutions, etc). • Perform media preparation, accurately measuring and dispensing, in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records • Collect environmental lab samples from multiple cleanrooms • Perform data entry of routine testing • Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records • Perform basic laboratory support functions such as laboratory inventory management, arranging for calibration and maintenance of equipment, lab housekeeping, and receiving of production samples and laboratory supplies • Assist in testing validation/revalidation activities for critical systems and equipment under close supervision • May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule • Update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations • Other incidental duties
Skills: • Good written and verbal communication, interpersonal, and relationship building skills • Able to read, comprehend, write and speak English • Good computer skills, including usage of MS Office • Moderate knowledge of laboratory processes • Moderate knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations • Moderate knowledge in mathematics, e.g., decimals and percentage • Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing • Strict attention to detail • Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment • Must be able to work in a team environment • Ability to provide feedback in a professional, direct, and tactful manner • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Education/Experience: • High school diploma or GED required. Associate's degree in medical technology or vocational training preferred. • 0-2 years experience required.