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Quality Assurance Technician

Millenniumsoft

Mebane, NC

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JOB DETAILS
SKILLS
Calibration, Continuous Improvement, Detail Oriented, Documentation, English Language, Equipment Validation, Establish Priorities, FDA (Food and Drug Administration), Hazardous Materials/Substances, High School Diploma, Lift/Move 25 Pounds, Manufacturing, Materials Analysis, Mathematics, Microsoft Office, Quality Assurance, Quality Control, Records Management, Reporting Skills, SAP, Safety Process, Sampling Inspection, Startup, Time Management, Writing Skills
LOCATION
Mebane, NC
POSTED
6 days ago
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.

About the Company

M

Millenniumsoft

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