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A global medical technology leader seeks an analytical laboratory member in Penang. You will conduct tests, maintain laboratory equipment, and follow strict FDA guidelines, contributing to transformative medical solutions while working within a dynamic team.
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Key Responsibilities
• Works as a member of the Penang Analytical Laboratory (PAL) Team to complete all required analysis in a timely manner.
• Capable of operating analytical instruments (HPLC, GCFID/MS, Karl Fischer, Dissolution Apparatus, UV-Vis and FTIR)
• Capable of preparing buffers, mobile phase, reagents and media needed for analysis
• Provide testing evaluation of raw materials, intermediates, and finished products samples based on specifications
• Perform investigations into suspected analytical lab testing results i.e. OOS, OOT, atypical data etc.
• Interprets and applies department policies and procedures and applicable laws, rules, and regulations
• Understand and precisely follows Standard Operating Procedures, global methods, local methods and published standard or compendia methods USP, AOCS, ASTM
• Render appropriate dispositions for all sample lots with test results outside specified limits
• Use analytical and problem solving skills to solve manufacturing issues/ problems related to Analytical Chemistry Science and contaminations.
• Maintain calibration of specific laboratory equipment as outlined in the calibration procedure
• Troubleshooting of Analytical equipment and associated Lab software
• Perform Analytical equipment qualifications, Analytical method validation/ verification activities
• Maintain standardization and replenishment of all laboratory volumetric solutions and reagents
• Ensure all samples no longer needed are boxed and properly identified for disposal
Requirements
• BSc or higher in chemistry or relevant scientific discipline
• Basic computer skills such as Word, Excel
• Ability to follow all methods and procedures in strict compliance with FDA cGLP guidelines
• Must be comfortable working on individual projects leading/participating in a team across various functions to deliver results on tight timelines
• Expertise and practical laboratory experience
• At least 1-2 years of experience with HPLC/ GCFID/MS along with other analytical instrumentation
• Excellent written, oral, and visual communication skills to communicate effectively with all levels and teams of the organization
About Us
As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.