QA Labeling Specialist

LGC Group•Milford, MA

4h•$60,000 - $81,000•Onsite

About The Position

Are you ready to play a key role in ensuring quality and compliance in a world-class organization? At LGC, 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. Join us and help us make a difference!

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.

Nice To Haves

Knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR EU/2017/746, and international regulatory requirements.
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.
Strong initiative and troubleshooting skills required.
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 is essential.

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.