Development scientist - united states, san jose
adecco is currently assisting a global supplier of scientific instrumentation, reagents and consumables, and software services in recruiting for development scientist in san jose, ca. this is 12-month assignment.
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shifts available: days
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pay rate: doe
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this position is responsible to lead the hardware testing and validation efforts, particularly focused on lc/ms applications using the triple quadrupole-based instruments to ensure comprehensive testing in compliance with fda and international regulatory standards.
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key responsibilities:
be a representative of the verification and validation department.
operate within the product development process and be familiar with the principles of working within a quality management system or regulated laboratories.
lead the verification and validation efforts for ivd products that are compliant with fda, ivdr and other international regulatory standards.
write documentation, such as test plans, protocols, and reports.
maintain documents that records all aspects of experimental design and results, following good documentation practices (gdp).
independently perform experiments and generate data in support of product requirements.
responsible for accuracy and completeness of auditable documents.
support risk management activities as a technical subject matter expert (fmea, hazard analysis, etc.)
work successfully with other departments- including but not limited to manufacturing, quality, regulatory, and marketing - for the development, transfer, submission, and commercialization of ivd products.
create and present formal design review presentations at key milestones.
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minimum requirements/qualifications:
ms degree and 6+ years; phd and 2+ years in chemistry or relevant field (biomedical engineering, biochemistry, etc.).
5-10 years’ work experience (including advanced degree studies) with hands-on experience operating and maintaining lcms with knowledge of method development, range of applications and software.
hands on experience working with lc liquid chromatography / ms- mass spectrometry
strong knowledge of both lc and ms instrumentation.
solid understanding in one or more of proteomics, lipidomics, pharma/biopharma, clinical or food & environmental analytical industries.
experience with ivd products and working under design control
proven understanding of design control for regulated products (e.g. fda, ivd, ivd-r, china and japan regulations) and knowledge of applicable regulatory and quality standards used in product development process (e.g. iso:13485 and 21 cfr 820)
good understanding of controlled documentation and data systems.
self-motivated and can work independently with minimal direction
demonstrated ability for high-quality results, technical proficiency, laboratory skills, collaboration with other departments.
great communication skills.
computer skills such as word and excel.
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why work for adecco?
weekly pay
401(k) plan
skills training
excellent medical, dental, and vision benefits
*this client requires proof of covid-19 at time of hire.
click on “apply” now to be considered for job is posted by adecco’s medical and science division, not your local adecco branch office.
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
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