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Quality Assurance Analyst in Laboratory Settings

vor 3 Monaten


Sankt Wendel, Saarland, Deutschland Fresenius Medical Care Vollzeit

Your Responsibilities

Conducting analyses using Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), as well as coupled Mass Spectrometry (GC-MS, LC-MS, LC-QTOF), and trace metal analysis (ICP-MS, ICP-OES) Performing chemical analyses in compliance with ISO/IEC 17025 standards Developing and validating new testing methodologies according to ICH Q2(R2), Q14, and similar guidelines Qualification, monitoring, and maintenance of laboratory equipment Ensuring the accuracy and reliability of test results Documentation and reporting in accordance with quality management systems Creating and reviewing Standard Operating Procedures (SOPs) within the area of responsibility Actively participating in training and professional development

Your Profile

Completed university degree in Chemistry, Analytics, or a related field (Biology, Biotechnology) At least three years of experience in a GMP environment preferred In-depth knowledge of instrumental analytics using GC, HPLC, Mass Spectrometry, and ICP-MS Several years of professional experience in an ISO/IEC 17025 accredited laboratory, as well as in the qualification and management of testing equipment Extensive experience in trace analysis and the area of Extractables/Leachables Exceptionally structured working style Strong analytical skills and problem-solving abilities Excellent proficiency in both German and English, spoken and written Experience with Laboratory Information Management Systems (LIMS) is desirable