About the position
Responsibilities
• Perform hands-on testing in the analytical chemistry laboratory, including sample preparation (extractions, solvent exchange, concentration), gravimetric determination of non-volatile residue, and preparation of standards and solutions
• Complete lab maintenance activities such as ordering, inventory management, glassware washing, equipment maintenance, and lab monitoring activities
• Support development, validation, and qualification of analytical methods
• Complete tasks on analytical lab documentation and quality records
• Prepare analysis summary reports/documentation to communicate results to lab customers and the technical community
• Familiarity with ISO 10993, ISO 17025, FDA, and other regulatory agency requirements for chemical characterization of medical device and combination products
• Apply scientific principles and company policies and procedures, analyze data or situations, and exercise judgment to recommend solutions to solve problems
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
Requirements
• Bachelor's degree or higher in chemistry-focused field with aptitude for analytical chemistry
• Experience in preparation of samples, standards, and laboratory solutions
• Familiarity with chromatographic analyses
• Strong organizational, communication, and collaboration skills
• Strong technical writing and scientific laboratory documentation skills
Nice-to-haves
• Bachelor's degree or higher in Chemistry
• Previous Boston Scientific experience preferred
• Experience performing extractions and non-volatile residue (NVR) analysis for chemical characterization analysis per ISO 10993
• Experience with laboratory ordering and inventory management
• Experience with HPLC or GC instrument analysis and troubleshooting
• Exposure to Chromatography Data Systems
• Experience applying ISO 10993 and ISO 17025 requirements to laboratory work
• Working experience in performing analyses and preparing documentation within FDA, ISO 17025, and other regulatory environments
• Analytical chemistry lab experience in medical device or pharmaceutical industries
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