3 days ago

Quality Assurance Documentation Technician (1-year contract)

Quotient

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Quality Assurance Documentation Technician (1-year contract)

Qu otient is a commercial - stage diagnostics company committed to increasing efficiencies and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and donor disease screening (transfusion diagnostics), Quotient is developing MosaiQ™ , its next generation automation p latform to address the comprehensive needs of the global transfusion diagnostics market. Once approved for sale, MosaiQ ™ will be the first fully automated solution for blood grouping, quickly and comprehensively characterizing both donor and patient blood, improving patient outcomes and eliminating the need for expensive and time - consuming manual testing. MosaiQ ™ will also undertake all mandated serological disease screening tests required for donor blood. Quotient has over 30 years of experience developing , manufacturing and commercializing transfusion diagnostic products. The company's operations are based in Switzerland, Scotland and the US. We are now recruiting for our next: Quality Assurance Documentation Technician (1 - year contract) ? Control of the documents of the Quality Management system as required per ISO13485 and FDA QSR 21CFR part 820. ? Check the compliance of the new or revised documents of the QMS to the requirements of the document control procedure. ? Register documents and related properties into the electronic system. ? Release , diffus e and track all the documents within the company related to the Quality System. ? Lead corrective actions and preventive actions (CAPA) related to his (her) activity. ? Provide monthly metrics for BMR reviews, Non - conforming material, d eviations, i ncidents, i ncoming inspection results and supplier monitoring review. ? Handle and improve the archiving process . ? Relevant diploma in Quality ? 1 to 3 year experience working in a Quality Assurance department in a GMP environment. ? Detail - oriented with strong verbal communications skills ? Effective team player with good organi s atio nal skills. ? Must be flexible to chan ging priorities. ? Fluent in English, French an asset .

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