Laboratory Microbiologist Position for Experienced Professional
hace 4 días
We are seeking a skilled Laboratory Microbiologist to join our team at Edwards Lifesciences. As a Laboratory Microbiologist, you will be responsible for providing testing services in a laboratory environment and ensuring compliance with established work instructions and SOPs.
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, receive, inspect, in-process solutions, etc.)
- Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
- Investigate 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 propose recommendations on template changes
- Assist with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis
- Create and develop validation plans for laboratory equipment and methods
- Lead laboratory investigations and propose recommendations and solutions for manager approval
- Propose and update operating procedures and ensure that specifications are in compliance with GMP
- Train, coach, and guide lower-level technicians on new procedures, assess work techniques, and provide feedback on procedures
- Technical Diploma in Microbiology, Laboratory, or Chemistry or Bachelor's Degree in Microbiology
- More than 3 years of previous experience working in a laboratory environment or in a microbiology environment
- Excellent written and verbal communication, interpersonal, and relationship-building skills
- Able to read, comprehend, write, and speak English (Intermediate level)
- Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g., ChemStation Empower)
- Full knowledge of laboratory processes
- Knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
- Ability to write technical documents
- Strong knowledge with ISO microbiological sterilization documents if applicable
- Strict attention to detail
- Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments
- Ability to provide feedback in a professional, direct, and tactful manner
- Ability to represent the organization to outside contacts, i.e., vendors
$85,000 - $110,000 per year, depending on experience
About Us:Edwards Lifesciences is a leading developer of healthcare technologies that improve lives worldwide. We are committed to advancing the science of cardiovascular disease through innovative medical devices and treatments.
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