Role & seniority
- Quality Assurance Administrator, Manufacturing Quality Assurance team; mid-level QA role.
Stack/tools
- Quality management systems and document control
- Change control processes, logs and tracking
- Batch records, certificates of analysis, raw material specifications
- Internal audit support and QA documentation workflow
Top 3 responsibilities
- Control, distribution, and administration of quality documentation; process and approve document change requests with stakeholder notification
- Maintain logs for documentation/tasks; perform incoming QA checks (raw material specs, COA verification, visual inspections) and batch record reviews
- Support the internal audit program and uphold adherence to the Quality Policy and system procedures
Must-have skills
- Degree in a relevant Science, Engineering, or QA discipline
- Some industry experience in a regulated environment for medical devices
- Basic knowledge of FDA 21CFR820, ISO13485, IVDD/IVDR and related international regulatory requirements
- Excellent communication skills and attention to detail
Nice-to-haves
- Prior experience in a medical devices/QMS environment
- Familiarity with document control workflows and quality system procedures
Location & work type
- Location not specified; work type not specified.

Full Description

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.

We're seeking a Quality Assurance Administrator to join our Manufacturing Quality Assurance team.

Job Description

Control, distribution, and administration of Quality documentation, which support Technopath’s quality management systems. Process and approve document change requests followed by providing notification of changes to controlled documents to relevant parties. Maintenance of various logs associated with tracking of documentation or tasks.

Incoming Quality Assurance: Maintain raw material specifications (file/update), complete check of raw material certificates of analysis, perform visual inspections. Perform batch record review. Support Technopath Internal Audit program. Performs other related duties as assigned by management. Demonstrate an understanding of the application of the Quality Policy through daily activities. Maintain vigilance to ensure adherence to the Quality Policy and system procedures by promptly reporting noncompliance issues to management.

Qualifications

Minimum of degree qualification in a relevant Science, Engineering or QA discipline Some industry experience working in a regulated environment for medical devices Basic knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR EU/2017/746 and international regulatory requirements Excellent communication skills and attention to detail

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!

#LGCIJ