Quality Assurance Specialist 2

Merck Life Science; Glasgow; On-site; GBP 40,000 - 60,000; Full time

Job summary

Join a forward-thinking company as a Quality Assurance Specialist II, where you'll play a pivotal role in managing supplier audits and ensuring compliance with regulatory standards. This exciting position involves leading the supplier external audit program, hosting customer audits, and overseeing the Quality Management System documentation. You'll have the opportunity to travel within Scotland, the UK, and Europe, making a significant impact on quality assurance processes. If you have a passion for quality and a keen eye for detail, this role is perfect for you to develop your career in a dynamic and supportive environment.

Qualifications

• 2+ years’ experience in a quality role is required.
• Degree in Biological Science or Quality Management is essential.

Responsibilities

• Lead and manage supplier external audit program in the UK.
• Host client audits and generate audit responses for the audit program.

Skills

Quality Assurance

Attention to Detail

Organizational Skills

Interpersonal Communication

Presentation Skills

Time Management

Training and Development

Education

Degree in Biological Science

Degree in Quality Management

Job description

Your role :

As a Quality Assurance Specialist II, you will be responsible for leading and managing our supplier external audit program in the UK and supporting activities within the client services team such as hosting client audits and generating audit responses for our client audit program. The successful candidate will be responsible for leading and coordinating the UK supplier schedule, conducting supplier audits, processing new vendors and reassessments, and coordinating and processing supplier complaints. Key duties include documenting and reporting on supplier audit inspections, reviewing and approving new suppliers, supplier questionnaires, supplier quality agreements, and managing supplier complaints to ensure regulatory compliance.

The successful candidate will also support the hosting of our customer audit program within the UK. Key duties will be hosting customer audits and coordinating audit activities (tours, document retrieval) with operations as well as coordinating audit responses and generating CAPAs related to customer audits. The role will also involve overseeing company Quality Management System (QMS) documentation, including Event (Deviations and Out of Specifications), CAPAs, Change Control, Effectiveness Checks, and SOPs. Your role will include travel within Scotland, the UK & Europe to conduct client & supplier audits.

Who you are:

• 2+ years’ experience in a quality role
• Hold a Degree or equivalent in a Biological Science or Quality Management
• Previous experience working within a quality-driven systems or regulated environment (GMP and GLP)
• Excellent attention to detail is essential as well as logical in thought
• Strong organisational skills
• Presentation & interpersonal communication skills
• Ability to set own work schedules to manage time and prioritise workload effectively
• Ability to train & develop functional skills in others and support colleagues cross-functionally on operational and transactional tasks