Job Description

Provide microbiological and chemistry testing services to the production line to support the manufacturing of heart valves.Key Responsibilities:

• Perform routine and non-routine testing services by using established procedures/protocols (e.g. manufacturing investigations, D-value, B&F, FETS, glut, TLS, antimicrobial, sterility, in process solutions, etc.)
• Perform laboratory investigations and propose recommendations and solutions for manager approval
• Perform investigations on CAPA forms e.g., NCRs, RICA, OOT, OOS, for tests or processes nonconformance and identify root cause and propose corrective actions for manager approval
• Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data and may propose recommendation on template changes
• Oversees the preparation of solutions
• 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 with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis
• Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
• May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures
• Other incidental duties assigned by Leadership

Education and Experience:
Associate\'s Degree or equivalent 5 Years years experience of previous experience working in a laboratory Required or
Bachelor\'s Degree in Chemistry and /or Microbiology PreferredAdditional Skills:

• Excellent written and verbal communication, interpersonal, and relationship building skills
• Able to read, comprehend, write and speak English
• Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g. ChemStation, Empower) preferred
• Full knowledge of laboratory processes
• Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
• Full knowledge in mathematics, e.g., decimals and percentages
• Ability to write technical documents
• Strong knowledge with ISO microbiological sterilization documents (micro only)
• Strict attention to detail
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• 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

Edwards Lifesciences