Quality Assurance Technician – Packaging & Documentation

Bio-Techne Corp.; Massachusetts; On-site; USD 32,000 - 44,000; Full time

Benefits offered by this job

Medical, dental, vision benefits from,

401k + ESPP

Tuition reimbursement

Job summary

Bio-Techne Corp. in Devens, MA, is hiring a Quality Assurance Technician to perform on-line in-process inspections, review device history records, and generate Certificates of Conformance.

This role supports labeling and packaging operations, non-conformance reporting, and documentation control in a GMP environment. Responsibilities include UDI barcode verification, CAPA support, and creating/maintaining LAR/eLAR records.

Qualifications

• High school diploma required; 3 years in labeling and packaging operations.
• Strong attention to detail and data review.
• Knowledge of cGMP, GDP, and quality systems.
• Ability to perform basic calculations and sampling.
• Proficient in computer applications and documentation control.

Responsibilities

• Inspect and approve lot-specific labels, packaging materials and printed information.
• Perform in-process inspections of labeling and packaging operations.
• Conduct finished goods inspections using AQL standards.
• Review device history records, packaging documentation, and production records.
• Prepare Certificates of Conformance and retain samples.
• Identify and escalate quality issues; initiate NCMRs.
• Support CAPA investigations and continuous improvement.
• UDI barcode verification and OEM quality support.
• Process and maintain work order packets and LAR/eLAR records.
• Manage label files, barcodes, and imprinting specifications.
• Ensure documentation is accurate and compliant; support COAs/COCs.

Skills

Attention to detail

Statistical sampling

cGMP & GDP knowledge

Documentation & control

Computer literacy

Time management

Communication skills

Education

High school diploma

3 years labeling/packaging operations experience

Tools

ERP systems

Labeling software

Job description

Bio-Techne Corp. in Devens, MA, is hiring a Quality Assurance Technician to perform on-line in-process inspections, review device history records, and generate Certificates of Conformance.

This role supports labeling and packaging operations, non-conformance reporting, and documentation control in a GMP environment. Responsibilities include UDI barcode verification, CAPA support, and creating/maintaining LAR/eLAR records.