Quality Assurance Technician - Labeling & Packaging

Bionostics, Inc.

Harvard (MA)

On-site

USD 32,000 - 44,000

Full time

5 days ago
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Benefits offered by this job

Medical, dental, vision insurance
401(k) with ESPP
HSA/FSA programs
Tuition reimbursement
Mentorship and training
Parental leave and paid time off
Volunteer time off

Job summary

Bio-Techne is seeking a Quality Assurance Technician to perform online in-process inspections of assemblies and device history records, review COAs/COCs, and support documentation. The role includes non-conformance handling, ERP reporting, and release activities for finished goods, alongside maintaining labeling accuracy and supplier quality controls.

The position requires attention to detail, familiarity with cGMP, GDP, and documentation practices, and the ability to adapt to changing

Qualifications

  • Experience in labeling and packaging operations.
  • Knowledge of cGMP and GDP requirements.
  • Strong attention to detail and accuracy in data review.
  • Ability to manage multiple tasks and meet deadlines.

Responsibilities

  • Inspect and approve lot-specific labels and packaging materials for accuracy and compliance.
  • Perform in-process inspections of labeling and packaging operations.
  • Conduct finished goods inspections using AQL standards and support product release.
  • Review device history records, packaging docs, and production records for completeness.
  • Prepare Certificates of Conformance (COCs) and maintain records.
  • Identify quality issues and initiate NCMRs as required.
  • Support CAPA investigations and continuous improvement activities.

Skills

Detail oriented
cGMP knowledge
GDP familiarity
Documentation practices
Statistical sampling
Cross-functional collaboration

Education

High school diploma

Job description

Bio-Techne is seeking a Quality Assurance Technician to perform online in-process inspections of assemblies and device history records, review COAs/COCs, and support documentation. The role includes non-conformance handling, ERP reporting, and release activities for finished goods, alongside maintaining labeling accuracy and supplier quality controls.

The position requires attention to detail, familiarity with cGMP, GDP, and documentation practices, and the ability to adapt to changing

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