Provide microbiological and/chemistry testing services in a laboratory environment or cleanroom environment.
Key Responsibilities:
- Perform routine testing services using established procedures/protocols (e.g. sterility, bioburden, aseptic filtration, environmental collection and testing, in process solutions, etc)
- 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
- Assist in testing validation/revalidation activities for critical systems and equipment under close supervision
- Update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
- May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule
Education and Experience:
Other: in NITEC or equivalent In related science field, 1 Year previous experience working in a laboratory environment Required or
Other: in Higher NITEC or equivalent In related science field Required or
Associate's Degree or equivalent in Diploma in related science field Preferred or
Bachelor's Degree In Related Science Field Preferred
Additional Skills:
- Good written and verbal communication, interpersonal, and relationship building skills
- 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 Edwards 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 and with close supervision
- 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
