Company 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 commercialisation activities across the entire diagnostic pipeline. Professionals in clinical chemistry, immunochemistry, serology, and molecular diagnostics rely on LGC's products for accurate diagnostic results.
Our exceptional team, scientific expertise, efficient operations, and quality systems support a range of advanced technologies daily, improving patient outcomes.
Job Description
Job Purpose
The Senior Quality Specialist position will advance LGC Clinical Diagnostics' purpose of Science for a Safer World by supporting and contributing to TNAC's product quality and Quality Management System processes. LGC Clinical Diagnostics' TNAC Kidlington location is seeking a candidate who is experienced with a working knowledge of quality system requirements to ISO 9001. The successful candidate will have a strong orientation toward continuous improvement.
Key Responsibilities
* Provide direction and guidance to the TNAC team in execution of and compliance with the Quality Management System.
* Maintain excellent communication with manager and site leadership to ensure quality issues are raised and addressed.
* Provide and document Quality training of new employees.
* Accurate review and approval of records comparing results to internal and customer specifications, SOPs, and established standards for product release.
* Ensure accurate QMS records related to nonconformances, deviations, and CAPAs.
* Review and approval of protocols, reports, and change management documentation ensuring defendable practices and conclusions.
* Utilise quality tools to track and trend quality performance and identify key opportunities for improvement.
* Work with functional groups to investigate quality issues, determine root cause, and suggest and implement corrective and preventive actions.
* Perform product release activities such as review of labels, batch records, and QC results.
* Process and approve document change requests followed by providing notification of changes to controlled documents to relevant parties.
* Perform internal audits, issue audit reports, and follow up to close out actions which address the findings.
* Promote and contribute to continuous improvement activities.
* Host audits and regulatory inspections.
* Provide advice to other departments to ensure compliance with company policies, procedures, and best practices.
* Provide training on new and existing SOPs and major updates to SOPs and maintain training records.
* Perform other related duties as assigned by management.
Knowledge, Experience and Technical Skills
* Strong interpersonal, organizational, verbal and written communication skills.
* Demonstrates curiosity, integrity, brilliance, respect, and passion; works best in a team environment and actively seeks to foster relationships.
* Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem-solving process.
* Oriented to continuous improvement.
* Impeccable attention to detail.
Qualifications
Education and/or Experience
* Minimum of a Bachelor's degree in a relevant Science, Engineering or QA discipline.
* 3+ years industry experience working in a Quality Assurance role in a regulated environment for medical devices, pharmaceutical, or biotechnology industry.
* Working knowledge of ISO 9001 or equivalent Quality Management System principles.
Additional Information
Our values
* PASSION
* CURIOSITY
* INTEGRITY
* BRILLIANCE
* RESPECT
Benefits
Join us and enjoy:
* 25 days holidays
* Life assurance & health allowance
* Discounts with local and national retailers
* Free 24/7 Employee Assistance Programme
* Recognition schemes and monetary awards
At LGC, we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know.
Join us in this outstanding opportunity to be part of a company that is leading advancements in the industry
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1. Work Arrangement: On-site
2. Department: Quality Assurance and Regulatory Affairs