The primary purpose of this job is to perform instrument assessment testing and data review prior to release of product within the Final Test QC department.
Job Summary The Senior Manufacturing Quality Technician will be responsible for carrying out product assessment testing complying with GMP and in accordance with Beckman Coulter, Inc. Chaska procedures. Timely and accurate completion of all related documentation is a key part of the role. Personnel will be responsible for reviewing and approving batch records prior to product release. Personnel will also ensure that the test area and equipment are maintained to a safe and compliant standard. Key Responsibilities • Perform QC assessment on ACCESS and UniCel DxI instruments. • Analyze problems / failures, troubleshoot and determine corrective action. • Ensure accuracy and traceability of records to comply with GMP, FDA and ISO requirements. • Review and approve instrument batch records. • Generate moderately complex data entry and FPY reports using six sigma / statistical methods. • Initiate changes to current SOPs. • Train other QC technicians or temporary technicians. • Perform other duties assigned by management
• AA degree in mechanical or electrical technician or related field with at least 3 years experience • Proficient with Microsoft Word and Excel. • Basic understanding of six sigma / statistical methods. • Ability to analyze data for trends and/or shifts and work with lead Principle technician to troubleshoot issues. • Knowledge and application of Lean Manufacturing. • Ability to build solid working relationships that enhance collaboration and cooperation with others. • Ability to adapt to changes. • Ability to prioritize daily/weekly work assignments to meet goals. • Ability to communicate effectively within the work unit by gathering and sharing information and/or ideas. • Familiarity with routine instrumentation and laboratory equipment • Ability to multitask and pay attention to detail. • Ability to follow routine procedures without supervision.
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