Quality Assurance Technician
Roles & Responsibilities
- Perform and document final inspections of production slides, vials, kits, and labels to quality specifications.
- Conduct incoming inspections of materials and analyze results against specifications.
- Ensure released materials are correctly accounted for and production documentation is accurate.
- Complete required Quality Control (QC) testing and documentation, determining correct disposition.
- Document nonconforming conditions and segregate nonconforming products.
- Support lab functions, including preparation of standards and reagents, and handle hazardous waste.
- Maintain retention samples and manage device history records.
- Adhere to safety procedures, including gowning and PPE.
- Participate in continuous improvement activities.
Experience Required
- High School Diploma/GED with a minimum of 2 years related QC or manufacturing experience.
- Basic knowledge of SAP is preferred.
- Experience in an FDA-regulated environment is desirable.
Skills & Certifications
- Proficiency in Microsoft Office.
- Understanding of sampling techniques and inspection standards.
- Basic math skills and ability to use Excel for calculations and graphing.
- Fluency in English (speaking, reading, writing) and ability to write technical reports.
- Attention to detail, strong observation skills, and ability to work independently.
- Ability to make critical decisions regarding product quality.
- Knowledge of validation, equipment calibration, and change requirements.
- Ability to prioritize tasks and meet deadlines.
Eligibilities & qualifications
- Ability to stand for long periods and lift 25 lbs.
- Ability to perform repetitive tasks.
- Must adhere to designated shift start-up times and flexible scheduling.
- Willingness to work overtime as needed.
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