Location: Irvine, CAThe Scientist I will use knowledge of scientific techniques to contribute to validation or qualification of external devices to be reprocessed in company products and designing and developing safe and effective company products in compliance to new product development procedures.
Responsibilities:Under supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
- Performs various routine laboratory studies and assignments to support the validation and qualification of medical devices for reprocessing in ASP sterilization and disinfection systems within the ASP Technical Business Solutions Team (TBS) and other ASP functions.
- Supports, or leads if needed, drafting of technical documents such as protocols, test reports, and technical reports using templates and examples from previous studies and communicate results to stakeholders, as needed.
- Expected to contribute to the organization and directions of experiments and perform experiments under supervision to evaluate the development and assessment of new technologies for potential products following the regulatory guidelines / standards (FDA, TGA, ISO etc.).
- Ensures that projects and experiments are carefully and diligently conducted, properly recorded, satisfactorily completed, and thoroughly summarized.
- Follows prepared protocols and designed experiments to execute research studies under supervision to support product development from feasibility to final product verification / validation
- Expected to demonstrate research and development techniques.
- Supports development of solutions to problems of limited to moderate scope and complexity through the exercise of judgment within defined practices and policies to determine appropriate actions.
- Effectively communicates experiment status / testing results to others.
- Requires a limited to full use of application of basic to standard principles, theories, concepts, and techniques
- Supports laboratory equipment validation program
- Supports OOS, CAPA, laboratory investigations, and other investigatory processes led by higher level scientists as needed.
- Must be able to provide training to other laboratory personnel in execution of testing procedures
- Responsible for communicating business related issues or opportunities to next management level.
- Performs other duties assigned as needed
Other Duties:- Provide support to other programs and project teams that require testing
- Support team focused on identifying and implementing process level efficiencies
- Support in maintaining awareness of the advances and needs in sterilization / disinfection, microbiology and biocompatibility
- Contribute to building extra ordinary team environment
QualificationsEducation:- Bachelor's Degree in a scientific discipline. such as Microbiology, Biology, or a closely related field.
Years of Related Experience:- 0-2 years in laboratory or related environment
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)
- Strong understanding of compliance with applicable laboratory and safety procedure is required
- Knowledge of sterilization, disinfection and cleaning technologies for reprocessing of medical devices is strongly preferred
- Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines is preferred
- The successful candidate must be self-driven, have strong critical thinking and problem-solving skills, and capable of working independently or in a team.
- Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment
- Working experience with sterilants and disinfectants is preferred
- Working experience with medical washer-disinfectors or sterilizers intended for reprocessing of medical devices is preferred
- Experience in validation or qualifying medical devices for reprocessing in medical washer-disinfectors or sterilizers is preferred
- Working knowledge of designs and features of medical devices is preferred
Bonus or EquityThis position is also eligible for bonus as part of the total compensation package.
Pay RangeThe salary range for this position (in local currency) is 65,090 - 108,675
