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Company Description
LGC Clinical Diagnostics Business Unit is comprised of our operating entities including LGC Clinical Diagnostics, Inc. (f / k / a Maine Standards Company & SeraCare Life Sciences), Technopath Clinical Diagnostics and the Native Antigen Company.
Our 400 employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), and an ISO 9001-accredited facility in Oxford, UK.
LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >
$510m of annual revenue and >
3,500 employees globally.
Job Description
Job Purpose
The QA Specialist III position will advance LGC purpose of understanding disease to enable precision diagnostics by supporting and contributing to LGC’s product quality and Quality Management System processes.
The successful candidate will have a strong orientation toward continuous improvement and the ability to act as a role model, change agent, and mentor.
The ideal candidate will be able to support and collaborate with commercial and manufacturing teams to ensure customer requirements are translated into internal specifications with continuous feedback loops for evaluating product and process performance as well as highly experienced with a working knowledge of quality system requirements, including FDA QSR / cGMP, ISO 13485 and ISO 14971.
Key Responsibilities
Assess excursions with appropriate deviations and / or risk evaluations.
Knowledge, Experience and Technical Skills
Qualifications
Additional Information
Last updated : 2024-03-23
Full Time
$104k-124k (estimate)
03/24/2024
04/06/2024
lgcgroup-llc.com
OVERLAND PARK, KS
200 - 500
1992
WILLIAM KRUEGER
$10M - $50M
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