Quality Assurance Technician

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

## Quality Assurance TechnicianApply: Devens, MA: Full time: Posted Yesterday: JR102230**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 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 **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.** **To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.** ***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.***