Quality Assurance Officer

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

QUALITY ASSURANCE OFFICER

AliveDx is recruiting for a Quality Assurance Officer to join the Quality Assurance team based near Penicuik, Edinburgh. The role is a full-time permanent position, working 37.5 hours per week.

The Quality Assurance (QA) team is a part of the wider Quality Department. The Quality Department is responsible for the management of quality and of the Quality Management System (QMS) within Alba's Good Manufacturing Practice (GMP) facility. QA's primary role concerns material management, ensuring satisfactory and timely release of all raw materials, in-process materials as well as final products. This is done by ensuring that all aspects of regulatory and GMP compliance are met during this process, ultimately delivering safe and effective products to the market.

YOUR MISSION

Your main responsibilities will include:

• Works within established procedures with a moderate degree of supervision
• QA release of incoming goods, intermediate and final product
• Ensure accurate recording and satisfactory completion (procedure and regulatory compliance) of all relevant documentation relating to the operation and work completed
• Conduct audits and checks in support of manufacturing and supply chain and other applicable quality processes.
• Assist with the maintenance of documentation and computerised systems including but not limited to records of incoming deliveries, batch manufacturing and test records, specifications, standard operating procedures and policies, enterprise resource planning (ERP) and QMS records
• Assists with monthly metrics for non-conforming material, incoming inspection results and supplier monitoring review
• Supports supplier complaints process to resolve issues with incoming raw materials.

YOUR COMPETENCIES

• Relevant work experience in a GMP environment.
• Good Communication skills and ability to demonstrate a collaborative approach.

• A proactive approach, explicit attention to detail.

• An effective team player with effective time management skills

WHAT WE OFFER

• A highly dynamic and growing environment.
• An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
• A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.

Interested? We look forward to receiving your application.