Job Description

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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