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.
Job DescriptionAre 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.
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.
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
#scienceforasaferworld
Skills Required
- Bachelor's degree or equivalent experience in a relevant field
- At least 2 years of industry experience in a regulated medical product environment
- Proficiency in Microsoft Word and Excel
- Proficiency in Adobe InDesign and/or NiceLabel Pro
- Knowledge of FDA 21 CFR 820, ISO 13485, IVDD 98/79/EC, IVDR EU 2017/746, and international regulatory requirements
LGC Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about LGC and has not been reviewed or approved by LGC.
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Healthcare Strength — Health, dental, and vision coverage with FSA/HSA options are consistently part of the package, and private medical is cited where applicable in the UK. Coverage is often characterized as solid alongside other core benefits.
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Retirement Support — Retirement offerings include a 401(k) with employer contribution in the U.S. and pension schemes in the UK, complemented by life and disability insurance. These elements are highlighted as part of a standard-to-competitive core package.
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Leave & Time Off Breadth — Paid time off, holidays, sick leave, and family leave are broadly available, with some sites offering a year‑end shutdown. Flexibility and local leave programs contribute to a generally well-rounded time‑off offering.
LGC Insights
What We Do
LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range. LGC’s tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimise food production; and continuously monitor and enhance the quality of food, the environment and consumer products. LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community. LGC’s core purpose of Science for a safer world and its core values of passion, curiosity, integrity, brilliance and respect, drive its culture. As of 30 June 2021, it employs 4,350 employees, of which over 1,175 employees hold PhD and/or master’s degrees. Its products and services are delivered by highly qualified and experienced teams, operating from a global network of accredited sites that showcase its scientific and manufacturing capabilities.
