Quality Documentation Technician

Overview

Tek Wissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. The job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer.

Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.

Position: Quality Documentation Technician

Duration: 3 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: 06:00 AM to 06:30 PM

Pay Rate: $21.00-$21.00/hr

• This is a QA Technician position based in Lenexa, KS.
• Responsible for performing in-process and final audits of Device History Records (DHR) to ensure quality, compliance, and accurate documentation within production areas.
• This role supports product disposition decisions by verifying adherence to DHR instructions and good documentation practices.

• Conduct in-process audits of DHR records during production
• Perform final review of completed DHR records to support product disposition
• Ensure quality and regulatory compliance by interacting with production leads and staff to confirm adherence to DHR instructions and good documentation practices
• Perform GEMBA observations within operations and follow up to ensure completion of corrective actions
• Conduct spot checks of in-process logbooks and related documentation
• Support quality assurance compliance for medical device production
• Perform additional duties as required to meet quality and operational objectives

• Bachelor’s degree with at least 1 year of quality or production experience in a medical device or pharmaceutical environment
• OR
• Associate degree with 3 years of relevant experience OR
• High school diploma with 5 years of relevant experience
• Strong attention to detail
• Ability to work independently or as part of a team with minimal supervision
• Ability to lift up to 50 pounds
• Computer literacy, including Microsoft Office and quality/inventory systems
• Experience in regulated manufacturing or production environments

• Knowledge of Good Manufacturing Practices (GMP)
• Experience with electronic quality systems such as Track Wise
• Familiarity with inventory or manufacturing documentation systems

Tek Wissen® Group is an equal opportunity employer supporting workforce diversity.

• Mid-Senior level

• Contract

• Other

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