Roles & Responsibilities
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 :
ITE or Diploma in related science field
Additional Skills :
Good written and verbal communication, interpersonal, and relationship building skillsGood computer skills, including usage of MS OfficeModerate knowledge of laboratory processesModerate knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulationsModerate knowledge in mathematics, e.g., decimals and percentageKnowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturingStrict attention to detailKnowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environmentMust be able to work in a team environment and with close supervisionAdhere 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 / controlTell employers what skills you have
Quality System
ISO
GMP
Microbiology
Administration
Gas Chromatography
Data Entry
Chemistry
MS Office
Attention to Detail
Filtration
Laboratory
Manufacturing