Overview:
Join Waters as an Analytical Chemist in our dynamic Reagent Kits department, where we are dedicated to advancing analytical sciences to improve health and safety outcomes worldwide. Our innovative team plays a vital role in developing high-quality in vitro diagnostic and research products that enhance laboratory efficiency and accuracy. By contributing to our mission, you will help ensure the reliability of essential diagnostic tools that impact patient care on a global scale.
Responsibilities:
* Conduct thorough analytical testing of reagent kits, including LC-MS, UV, and KF assays.
* Ensure compliance with regulatory standards during product release testing and QC processes.
* Generate and analyze test protocols, producing detailed reports in line with quality management requirements.
* Support on-market product investigations and process changes to enhance customer satisfaction.
* Implement continuous improvement initiatives to boost quality, productivity, and cost-effectiveness.
* Maintain meticulous documentation and experimental records in accordance with laboratory SOPs
Qualifications:
Education: A degree in a scientific discipline with a strong chemistry component or equivalent experience.
Experience:
* Proven laboratory experience with analytical equipment such as HPLC or UPLC, and familiarity with LC/MS/MS preferred.
* Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP), including Non-conformances, Change Control and CAPA systems.
* Experience in a regulated environment (pharmaceutical or medical advice) is advantageous, ISO13485 & 21CFR820.
* Familiarity with basic laboratory procedures, including gravimetric and volumetric preparations.
* Prior experience with Biological Safety (L2) Laboratory would be a distinct advantage.
* Proficiency in Microsoft Excel is required, with the ability to use Macros is desirable.
Proficiencies:
* Be highly goal-oriented and organized, and be able to thrive in an atmosphere of shifting demands and priorities.
* Strong problem-solving skills and ability to troubleshoot technical issues.
* Excellent attention to detail with a focus on quality and compliance.
* Ability to work independently and collaboratively with cross-functional teams.
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