Quality Assurance Technician

Bio-Techne • Devens, MA

12d

About The Position

The Quality Assurance Technician conducts 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 release of in-house printed labels, and ERP reporting of finished goods and retains. The position also supports customer-specific reports and programs and assists the documentation group as required.

The role covers packaging quality control and documentation support. It includes checking labels and packaging, inspecting operations and finished goods, reviewing production records, preparing certificates, maintaining retains, supporting quality investigations and improvements, and managing manufacturing and labeling documentation. The technician follows company policies, SOPs, safety requirements, cGMP regulations, and record-management requirements, while adapting to changing priorities and supporting team objectives.

Requirements

• High school diploma.
• Three years of experience in Labeling and Packaging Operations.
• Strong attention to detail and 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.
• Proficiency in computer applications and 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 and ability to collaborate effectively across all levels of the organization.

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.
• 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 process, 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.

Benefits

• Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401k plans.
• Employee stock purchase plan (ESPP).
• Health Savings Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• Mentorship, promotional opportunities, training and development, and tuition reimbursement.
• Internship programs.
• Employee resource groups, volunteer paid time off, employee events, and charity drives.
• Accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED