Job Description

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.

Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.

Each day, our world-class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.

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!

Duties:

• 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.

Qualifications

Minimum Qualifications:

• 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.

Preferred Qualifications:

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

Behavioural & Interpersonal Proficiencies:

• 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.

Additional Information

The customary salary range for this position is:

Minimum pay rate $55,000 USD

Maximum pay rate $82,000 USD

The salary range provided covers the minimum and maximum amounts projected for this role. The base salary will be influenced by factors like experience, skills, and location.

All your information will be kept confidential according to EEO guidelines.

Join LGC and become part of a team that values collaboration, integrity, and brilliance in all we do. We are committed to encouraging a workplace where everyone can thrive and contribute to our mission.

Our values:

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

Equal opportunities

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, parental responsibilities, religion, or belief. Shortlisting, interviewing, and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

This position requires current U.S. work authorization. We are unable to sponsor or assume sponsorship for temporary visas (including H‑1B, H‑2B, OPT, O‑1, TN)

For more information about LGC, please visit our website www.lgcgroup.com

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