QA Labeling Specialist

LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

About the role

We are looking for a dedicated QA Labeling Specialist to join our ambitious engineering team. As a part of our growing community, you will contribute to projects that impact global health and safety standards.

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.

Requirements

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

Qualifications

• Knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR EU/2017/746, and international regulatory requirements.

Skills

• Strong initiative and troubleshooting skills.
• Strong interpersonal skills and the ability to communicate well – verbally and in writing.
• Strong attention to detail combined with consistently precise work.
• Ability to multitask and determine priorities.
• Resonate and operate in line with LGC’s core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect.
• Promote cooperation and dedication within a team to achieve goals and deliverables.

Pay

The customary salary range for this position is $55,000 USD to $82,000 USD. The base salary will be influenced by factors like experience, skills, and location.