Quality Assurance Specialist - 15-months FTC

Description

The company is a healthcare and diagnostics business with more than 100,000 employees worldwide, working to advance science and give people access to healthcare now and in future.

The team is the Operations Quality Assurance (OPSQ) Product Partnering Team, which provides quality support and expertise across many operations departments, with a focus on assay production.

Two Senior Quality Partner roles are open in Central Scotland. Each is a fixed term contract running from January 2027 to March 2028 and covers maternity leave.

Responsibilities

• Work with operations to make sure company procedures, applicable regulations and standards, including FDA requirements, the EU In Vitro Diagnostics Directive and ISO 13485, are followed during manufacturing.
• Advise operations partners on quality issues in manufacturing and quality control, including supply chain and supplier quality topics.
• Support business partners by reviewing and approving documents, templates and records so that product quality and compliance are maintained.
• Support business partners with non-conformances by reviewing and approving them and taking part in investigations to find solutions.
• Review and approve changes and deviations, supporting business partners so product quality and compliance hold.
• Work proactively with business partners to stay audit ready and build a culture of quality compliance.
• Support the team's product care and product improvement work, and quality activities across the area you cover.
• Ensure product quality, compliance with regulatory requirements and the quality management system, and proper documentation of all activities.
• Support special quality projects and initiatives, and optimise processes to raise quality and efficiency.
• Review batch records, manage documentation, troubleshoot, support non-conformance, change and deviation work, and support audits.
• Coach and train colleagues on quality topics, and contribute to process innovation and continuous improvement.

Requirements

• Hold expert knowledge of quality management.
• Be solution driven and results focused, committed to both day-to-day delivery and long-term initiatives.
• Communicate well and build strong stakeholder relationships that encourage collaboration.
• Be able to work independently, make decisive calls, and also be a strong team player.

Conditions

Fixed term contract from January 2027 to March 2028, covering maternity leave.

Based in Central Scotland.

The company is an equal opportunity employer.