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Fremont, CA, 94536, US
Job details
Work flexiblity: Onsite
Req ID: R532992
Employee type: Full Time
Job category: RAQA
Travel: 10%
Relocation: Yes
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Job description
What you will do:
- Support new product development and changes to medical devices currently on the market through executing analytical chemistry testing.
- Support day-to-day lab activities including coordination of preventative maintenance, calibration, purchasing, lab metrics, and sample organization activities.
- Conduct analysis using FTIR, ICP-MS, XRF, UV Vis, and TOC as well as other laboratory equipment.
- Own departmental initiatives including setting timelines and milestones.
- Interpretation, evaluation and reporting of test data.
- Maintain communications with internal customers on chemical analysis.
- Partner with cross functional teams including (RA, R&D, Ops) to ensure project timelines are met.
- Present lab KPIs to management and cross-functional partners.
- Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
- Own root cause analysis, equipment trouble shooting, and out-of-specification investigations.
- Own validation activities within the lab.
- Train junior scientists and other functions in area of analytical chemistry.
What are we looking for:
- BS in Chemistry/Biochemistry or related field 2+ years of medical device, pharmaceutical or chemical industry
- or MS in Chemistry/Biochemistry or related field with 1+ years of medical device, pharmaceutical, or chemical industry testing lab
Preferred Skills:
- Working knowledge of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP)
- Demonstrated ability to manage day-to-day activities within a chemistry lab.
- Knowledge of cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to residual chemical analysis for medical devices.
- Must possess effective communication, project management and influencing skills as well as can manage multiple tasks simultaneously.
- Excellent written and oral communication skills, including strong formal presentation and analytical skills.
- Scientific and technical writing and leadership skill