Packaging QA Technician – GMP, Documentation & CI

Bio-Techne; Harvard (MA); Vor Ort; USD 32.000 - 44.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

Long-term disability

Pet insurance

Legal shield

401k plan

ESPP

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Statistical sampling

GDP

cGMP

Data review

Time management

Communication

Multi-tasking

Ausbildung

High school diploma

Jobbeschreibung

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.