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19 days old

Development Scientist

Kelly Services
San Jose, CA 95115
**Location: San Jose, Ca**


**Contract Length: 12 months**


**Pay Rate: $48.76 per hour-negotiable**


**Position Summary:**


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.


**Key Responsibilities Include:**


+ Be an integral member on project core teams as 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.

+ 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.


**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.

+ 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.

+ Ability to present and communicate (oral and written) information in a clear manner.

+ Computer skills such as Word and Excel.


**Non-Negotiable Hiring Criteria:**


+ Degree in a scientific discipline, hands on LC/MS applications, experience working with IVD products or in a regulatory environment.


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-09 Expires: 2022-10-10

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Development Scientist

Kelly Services
San Jose, CA 95115

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