Provide testing services in a laboratory environment.
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
- 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
- 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
- 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
Technical Diploma in Microbiology, Laboratory or Chemistry. Required
or Bachelor's Degree in Chemistry and/or Microbiology or related field. Preferred.
Experience
3 years of previous experience working in a laboratory environment. Required.
- Availability to work in shift A or B*
Additional Skills
- 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
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
- 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.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 18,500 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**Know your Rights**: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
