Systems Qualification Scientist
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Systems Qualification Scientist
Title:Systems Qualification Scientist
Our premier client in Milford, MA is looking to hire a Systems Qualification Scientist. This is a long term contract position with possibility of Contract to Hire.
Overview of the Systems Qualification Scientist
This position represents an exciting opportunity for a scientist to perform qualification and evaluation This position will report directly to the Sustaining Qualification Team Manager in which the individual will help create, execute and validate Qualification protocols for systems and solutions. The individual will work closely with Waters R&D, GSS and Marketing in order to continuously develop product features and functionality.
Ensure that quality system procedures and Health & Safety standards are adhered to at all times.
Develop and maintain qualification methods for LC/MS/CDS systems and also stand-alone instruments.
Design and develop/maintain test cases relevant to Qualification method testing and evaluation.
Provide supporting documentation as required by the development process
Works collaboratively across the Waters organization, with product marketing, development, engineering, global service support, new product development, quality and R&D on current, new products and solutions that will better meet customer business objectives.
- A Bachelors Degree or equivalent preferably in Chemistry, Analytical Chemistry, Biochemistry, Physics, related science field of study
- Relevant, hands-on knowledge of Mass Spectrometry and Chromatography and their real-world application, gained through industrial experience with a supplier or user of these technologies.
- Previous experience developing and evaluating System Qualification procedures, protocols and tests for LC/MS systems strong preferred.
- Previous technical experience setting up, operating, maintain and troubleshooting LC/MS technologies strongly preferred
- Experienced evaluating, qualifying, validating instrumentation within highly regulated environments strong preferred.
- A deep understanding of experimental design and the fundamentals of analytical science
- Ability to work with process.
- Experience working in a regulated environment.
- Experience and knowledge of writing SOP in a regulated environment.
- Performed and written protocols for use in a regulated environment.
- Use of software packages (for example; IBM DOORS) to capture, trace, analyze and manage qualification activity to comply with a highly regulated quality process to maintain standards.
- Excellent organizational, numerical, verbal and written communication skills.
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