Quality Assurance Technician

Bio-Techne Singapore; Harvard (MA); Sur place; USD 32 000 - 44 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401k plan

ESPP

Résumé du poste

Bio-Techne seeks a Quality Assurance Technician to perform online in-process inspections of assemblies and device history records, generate COCs, and support documentation groups as needed.

The role covers packaging QC activities, label verification, ERP reporting of finished goods, CAPA support, and continuous improvement initiatives, ensuring compliance with cGMP and GDP guidelines within a fast paced manufacturing environment in Massachusetts.

Qualifications

• 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.

Responsabilités

• 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.
• 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

Connaissances

Attention to detail

cGMP knowledge

GDP knowledge

Quality systems

Written and verbal communication

10-key typing

Time management

Cross-functional collaboration

Formation

High school diploma

3 years experience in Labeling and Packaging Operations

Outils

ERP systems

Labeling software

Description du poste

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 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

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.