Quality Assurance Technician

Bio-Techne; Harvard (MA); On-site; USD 32,000 - 44,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

Long-term disability

Pet insurance

Legal shield

401k plan

ESPP

Job summary

Bio-Techne is seeking a Quality Assurance Technician to perform on-line in-process inspections and final device history-record reviews. The role includes generating COCs, handling non-conformances, and supporting documentation control and ERP reporting for finished goods.

The position emphasizes adherence to cGMP and GDP, thorough labeling and packaging inspections, and collaboration with the documentation group on COAs/COCs.

Qualifications

• High school diploma and 3 years' experience in labeling and packaging operations.
• Strong attention to detail and ability to review data accurately.
• Knowledge of cGMP, GDP and quality systems.

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 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 NCMRs as required.
• Support investigations, CAPA, and continuous improvement activities.
• Perform UDI barcode verification and OEM-specific quality support activities.

Skills

Attention to detail

Statistical sampling

GDP

cGMP

Data review

Time management

Communication

Multi-tasking

Education

High school diploma

Job description

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.

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 escape 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

QUALIFICATIONS

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.

Why Join Bio-Techne:

We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.

We invest in our employees' financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.

We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.

We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.

We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.

We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an E-Verify Employer in the United States.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [e-mail] for assistance.