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Quality Assurance Officer

Posted Date: 07-Jul-2021

Location: Eysins, VD, CH, 1262

Company: Quotient

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage
diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.  Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Newtown/Pennsylvania.

 

Quality assurance Officer

 

Quotient is recruiting for a Quality Assurance Officer to join the Operative Quality Department based in Eysins. The role is a full-time and temporary position until end of March 2022.

 

The Quality Assurance Officer is responsible for completing Operational Quality activities relating to raw materials, intermediate and final products in accordance with operational objectives, statutory regulatory requirements and the principles of Good Manufacturing Practice.

 

JOB DESCRIPTION

The main responsibilities will include:

 

  • Participate in QA release of incoming goods, intermediate and finished product;
  • Assist with the maintenance of documentation and computerised systems;
  • Responsible for inspecting and approving product labels and Instructions for Use;
  • Ensure the accurate recording and satisfactory completion of all relevant documentation relating to the operation and work completed;
  • Conduct QA checks and audits in support of the manufacturing process;
  • Provide monthly metrics (i.e. for Non-Conforming material, Incoming inspection results and supplier monitoring review);
  • Ensure that incidents, deviations and other quality system requirements are captured, reported, fully investigated and root cause established.

 

QUALIFICATIONS & EXPERIENCE REQUIRED

  • Bachelor’s degree in Science or equivalent (Pharmaceutical/Biotechnologies…);
  • Relevant work experience in a QA department within a GMP environment;
  • Relevant knowledge of ISO 9001/13485 standards;
  • Demonstrate ability to analyse the information in a structured manner and ability to prepare coherent report;
  • Good Communication skills and ability to demonstrate a collaborative approach;
  • Effective time management and good organisational skills;
  • Excellent spoken and written English (French is an asset).