GENinCode Predictive Genetics
QA & RA Associate
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FULL TIME QA & RA Associate _IN-VITRO DIAGNOSTIC MANUFACTURING (GENETIC TESTING). SALARY up to £40,000 DEPENDANT UPON EXPERIENCE + BENEFITS
Company Description
GENinCode is a leader in advanced genomic technology, offering innovative solutions for the prediction and management of cardiovascular disease, thrombosis, and familial hypercholesterolemia. Leveraging both traditional clinical measures and genetic information, the company provides comprehensive risk assessments and clinical guidance to healthcare professionals.
Role Description
This is a full-time, on-site role located in Hammersmith for a Quality Assurance and Regulatory Associate. The responsibilities include conducting quality assurance and quality control activities, implementing quality management processes, and ensuring compliance with regulatory and operational standards. The role involves analyzing processes and systems to identify areas for improvement, maintaining documentation, and actively supporting the continuous enhancement of quality standards within the organization.
Duties and Responsibilities
- Support the company Quality Management System (QMS) processes such as Complaints, Non-conformance, CAPA, Change Control, and Risk Management processes liaising with internal subject matter experts as applicable.
- Support manufacturing and analytical method validation activities as and when required, writing and/or reviewing validation plans and reports as assigned.
- Provide guidance to the rest of the organization for effectively implementing and ensuring compliance with the requirements of the applicable regulatory agencies, standards, and regulations.
- Work with the Development team to ensure smooth and timely introduction of new products, participating in the product design stages including design reviews and product verification and validation for both reagent kits and bioinformatics pipeline.
- Support external computerized systems validation program.
- Perform internal and external audits as required.
- Manage Post-market surveillance program, liaising with appropriate stakeholders, and compiling the annual Product Reports for GENinCode assigned products, including those manufactured by external contractors.
- Attend meetings and participate in new projects as designated by line manager.
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The Candidate
You will join the corporate QA & RA team, providing support to all GENinCode sites in UK, EU, and US.
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You MUST have:
- A degree or equivalent in Science.
- Good knowledge of applicable regulations for In-Vitro Diagnostics Devices or Medical Device (software).
- Good Knowledge of Medical laboratories Requirements (ISO 15189) and laboratory processes.
- Good experience of working with Change Controls, NCRs, and CAPAs.
- At least 2 years of experience working within a QA Dept.
Skills Required:
- Good interpersonal and communication skills. Personable and able to communicate with staff of all levels. Able to work cross-functionally.
- Work effectively, independently and under supervision, being able to adapt to a fast pace rapidly changing environment. Flexible approach to work and the tasks to be undertaken.
- Fluent in English (oral and written) - main language used within the company for internal communications and all QMS documents.
- Other EU spoken languages desirable.
- Essential Microsoft Office package knowledge.
The Package
- Up to £40,000 subject to experience.
- Full Time Permanent Role.
- Excellent company benefits.
- Leading genetic testing organisation.
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