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 of the Quality Technician:
The Manufacturing Quality Technician will be responsible for carrying out product assessment testing complying with GMP and in accordance with procedures. Timely and accurate completion of all related documentation is a key part of the role.
- 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.
Qualifications of the Quality Technician:
• AA degree in Mechanical or Electrical Technology AND a minimum of 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.