Quality Assurance Technician

About the role

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range

$23.20 - $31.90

Position Summary

The Quality Assurance Technician is responsible for conducting periodic on-line in-process inspections of assemblies and device history records, final device history-record reviews, Certificate of Conformance generation, non-conformance generation as applicable, review and releasing of in-house printed labels, ERP reporting of finished goods and retains. This position also supports several customer specific reports and programs and assists documentation group as required.

Packaging QC responsibilities

• Inspect and approve lot-specific labels, packaging materials, and printed information for accuracy and compliance.
• Perform in-process inspections of labeling and packaging operations to verify product quality, component accuracy, and packaging requirements.
• Conduct finished goods inspections using AQL standards and support timely product release.
• Review device history records, packaging documentation, and production records for completeness and accuracy.
• Collect and maintain product retains and prepare Certificates of Conformance (COCs).
• Identify, document, and escalate quality issues; initiate Nonconforming Material Reports (NCMRs) as required.
• Support investigations, corrective actions (CAPA), and continuous improvement activities.
• Perform UDI barcode verification and OEM-specific quality support activities, including customer sample submissions.

Documentation support responsibilities

• Process and maintain work order packets to support manufacturing operations.
• Generate, enter, and verify lot assignment records (LAR/eLAR) and related product information.
• Configure, verify, and maintain label files, barcodes, and imprinting specifications using approved software systems.
• Ensure documentation is accurate, complete, and compliant with record management requirements.
• Support document control activities, including Certificates of Analysis (COAs), Certificates of Conformance (COCs), infocards, and document packet updates.
• Distribute and maintain production and labeling records as required.
• Review procedures and recommend processes, system, and documentation improvements.
• Adhere to company policies, SOPs, safety requirements, and cGMP regulations.
• Adapt to changing business priorities, manage workload effectively, and support team objectives.
• Perform additional duties and projects as assigned

Education and Experience

• High school diploma
• 3 years' experience in Labeling and Packaging Operations.

Knowledge, Skills, and Abilities

• Strong attention to detail with the ability to accurately review data, perform basic calculations, and apply statistical sampling methods. Knowledge of cGMP requirements, Quality Systems, and Good Documentation Practices (GDP).
• Ability to ensure labeling, packaging, and documentation activities comply with quality standards and customer requirements.
• Proficient in computer applications with strong organizational and time management skills.
• Ability to manage multiple priorities, meet deadlines, and adapt to changing schedules and business needs.
• Effective written and verbal communication skills.
• Efficiency with keyboard and 10 key typing.
• Strong interpersonal skills with the ability to collaborate effectively across all levels of the organization.