Quality Assurance Technician
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA, Regulatory Compliance Specialist
Job Description & How to Apply Below
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 SummaryThe 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.
Key Responsibilities- 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 elevate 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.
- High school diploma 3 years' experience in Labeling and Packaging Operations.
- 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.
- We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short‑term disability, long‑term disability, pet, and legal and d.
- We invest in our employees’ financial futures…
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