Perform targeted analyte content and release/elution testing using validated HPLC methods and other routine analytical techniques, including GC, FTIR, and GPC Execute accurate sample preparation across biological matrices, extracts, polymer materials, and catheter components Operate analytical instruments, complete system suitability checks, and perform basic troubleshooting and routine maintenance Review data for accuracy, proper calibration, integration quality, and compliance with method and QMS requirements Document all testing activities in accordance with Good Documentation Practices, ensuring complete and audit-ready records Receive, log, label, and sequence samples correctly within analytical batches Escalate deviations, instrument issues, or atypical results promptly to supervisory staff Support test method validation and method transfer activities as assigned Maintain laboratory cleanliness, chemical inventory, safe practices, PPE compliance, and QMS procedures Participate in required training, cross-training, and competency assessments Support R&D, Manufacturing, Quality, and Biocompatibility groups within Analytical Chemistry Shared Services Support uninterrupted laboratory operations and successful TMV execution at the Lab Supervisor’s direction Requirements Bachelor’s Degree in Chemistry, Biochemistry, or a related scientific discipline Minimum 2 years experience performing analytical chemistry testing in a regulated laboratory (medical device, pharmaceutical, or similar) Hands-on experience with HPLC and/or GC-MS instrumentation Experience with targeted analyte testing in analytical and biological matrices strongly preferred Proficiency in analytical sample preparation and execution of chromatographic/spectroscopic methods Ability to interpret analytical results, apply system suitability requirements, and recognize assay failures Strong attention to detail and adherence to documented procedures Competence with laboratory software (e.g., ChemStation, LIMS, Excel) Effective communication and ability to work within a multi-disciplinary team Ability to prioritize work in a fast-paced lab environment with minimal supervision Interpersonal skills; working in a team and as an individual contributor Ability to foster a positive culture of growth, collaboration, and achievement Ability to follow FDA, ICH, ISO 17025, and internal QMS requirements Ability to work in an office and laboratory environment Willingness to travel as required (up to 5% stated in working conditions; 10% in job details) Core Competencies Demonstrates expertise in analytical chemistry testing, particularly with HPLC and GC-MS instrumentation, while ensuring compliance with FDA, ICH, ISO 17025, and internal QMS requirements. Proficient in sample preparation, data review, and maintaining laboratory standards in a regulated environment. Highest-signal resume keywords HPLC Instrumentation GC-MS Instrumentation Analytical Sample Preparation Regulated Laboratory Experience Good Documentation Practices Hard Skills HPLC GC FTIR GPC Analytical Chemistry Testing Chromatographic Methods Spectroscopic Methods Data Review System Suitability Checks Method Validation Soft Skills Attention to Detail Effective Communication Team Collaboration Interpersonal Skills Ability to Prioritize Industry Keywords FDA ICH ISO 17025 QMS Biocompatibility Medical Device Pharmaceutical Tools & Technologies ChemStation LIMS Excel #J-18808-Ljbffr
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