QA Labeling Specialist: Precision & Compliance

SeraCare Clinical Diagnostics; Milford (MA); On-site; USD 55,000 - 82,000; Full time

Job summary

LGC Clinical Diagnostics in Milford, MA, is seeking a QA Labeling Specialist to ensure quality and compliance in labeling for a broad diagnostics portfolio.

You will generate, review, and approve labeling documents, IFUs, and master documents, while coordinating with product teams and ensuring regulatory alignment.

This role demands attention to detail, strong documentation skills, and the ability to manage multiple labeling projects in a fast-paced, global environment.

Qualifications

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

Responsibilities

• Generate, review, and approve all 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.

Skills

Attention to detail

Documentation

Communication skills

Education

Bachelor’s degree or equivalent experience

Tools

Microsoft Word

Excel

Adobe InDesign

NiceLabel Pro

Job description

LGC Clinical Diagnostics in Milford, MA, is seeking a QA Labeling Specialist to ensure quality and compliance in labeling for a broad diagnostics portfolio.

You will generate, review, and approve labeling documents, IFUs, and master documents, while coordinating with product teams and ensuring regulatory alignment.

This role demands attention to detail, strong documentation skills, and the ability to manage multiple labeling projects in a fast-paced, global environment.