QA Labeling Specialist — Impact Global Health Compliance

LGC Clinical Diagnostics; Milford (MA); Sur place; USD 55 000 - 82 000; Plein temps

Résumé du poste

LGC Clinical Diagnostics in Milford, MA is seeking a QA Labeling Specialist to join our engineering team and contribute to quality and compliance.

You will generate, review, and approve labeling documentation, support labeling projects for new products and changes, and ensure accurate lot-specific labeling and IFU templates. The role demands attention to detail, strong communication, and experience in a regulated medical product environment.

Qualifications

• Bachelor’s Degree or equivalent experience in a relevant field.
• Minimum 2+ years of industry experience working in a regulated medical product environment.
• Proficient in Microsoft Word, Excel, Adobe InDesign and/or NiceLabel Pro software.

Responsabilités

• Generate, review, and approve QA Labeling documentation with outstanding attention to detail.
• Support all QA labeling projects for the introduction of new products, product improvements, and labeling master document changes.
• Review and approve lot-specific production labeling to guarantee perfect adherence.
• Populate, review, and approve instructions for use (IFU) including lot-specific technical data when relevant.
• Complete, examine, and authorize IFU templates containing the revised lot-specific technical information.
• Populate, review, and approve lot-specific technical data and upload it to the relevant technical or resource library.
• Process all updated labeling documents through ETQ with proven accuracy.
• Update, review, and approve changes to the master labeling documents, including labels, packaging specifications, and IFUs.
• Complete verification of master labeling IFU updates on the auto-population electronic IFU software system.
• Upload QA labeling documents and customer communications to the relevant technical or resource library and website.
• Collaborate with applicable functional areas on build control and change control projects related to QA labeling.
• Keep designated areas clean and orderly while adhering closely to all workplace health and safety regulations.
• Perform other related duties as assigned by management.

Connaissances

Attention to detail

Troubleshooting

Communication

Formation

Bachelor’s Degree or equivalent experience in a relevant field

2+ years regulated medical product experience

Outils

Microsoft Word

Excel

Adobe InDesign

NiceLabel Pro

Description du poste

LGC Clinical Diagnostics in Milford, MA is seeking a QA Labeling Specialist to join our engineering team and contribute to quality and compliance.

You will generate, review, and approve labeling documentation, support labeling projects for new products and changes, and ensure accurate lot-specific labeling and IFU templates. The role demands attention to detail, strong communication, and experience in a regulated medical product environment.