Quality Specialist 3

Biopharma Careers; Stirling; On-site; GBP 36,000 - 48,000; Full time

Job summary

Biopharma Careers in Stirling is seeking a Quality Assurance Specialist to promote quality across the business and ensure compliance with GxP and SOPs.

You will review and approve GxP documents, perform data audits on testing records, and conduct in-process and product quality audits across Operations to minimize quality findings. The role reports to the Quality Manager. You will collaborate with teams to drive continuous improvement in a fast-paced, growing environment.

Qualifications

• Degree or equivalent in Biological Science or Quality Management
• Laboratory experience and exposure to GLP/GMP quality systems
• Motivated self-starter able to manage scheduled work
• Excellent interpersonal and communication skills
• Ability to balance multiple issues and adapt to change

Responsibilities

• Review and approve GxP documents (protocols, TS, SOPs)
• Perform data audits and approve testing documentation
• Conduct in-process and product quality audits across Operations
• Collaborate with operational teams to reduce quality findings
• Support regulatory compliance with GMP/GLP standards

Skills

Quality mindset

Prioritization

Communication skills

Leadership

Problem solving

Education

Degree in Biological Science or Quality Management

Job description

Your Role:

We have an excellent opportunity for a Quality Assurance Specialist to join our team in Stirling. As Quality Assurance Specialist you are responsible for promoting and integrating quality into every aspect of our business and ensuring that we are operating in full compliance with sound scientific practice, GxP and standard operating procedures. You will report to Quality Manager / Supervisor and will perform the review / approval of GxP documents, including protocols, technical specification (TS) and SOPs. You will perform data audit and approval of completed testing documentation as they align with the stated regulatory standard and the approved TS, protocol or SOPs. You will also conduct in -process and product quality audits across Operations areas to ensure compliance to the Quality Management System, GMP or GLP Regulatory Standards, relevant Standard Operating Procedure (SOP's) and customer specification and constantly work within Operational departments to reduce the risk of quality findings.

Who you are:

Degree or equivalent in a Biological Science or Quality Management

Previous experience of working within a laboratory environment and working within quality driven systems and / or a regulated environment (GLP/GMP)

Be highly motivated, self-starter demonstrating ability to use initiative with respect to scheduled work activities

Excellent interpersonal skills with the ability to priorities own workload, work to tight schedules and adaptable to change

The ability to thrive in a fast paced and growing environment, while using sound judgment to resolve complex issues and challenges. Comfortable initiating change. Ability to balancing multiple issues and perspectives.

Excellent leadership, facilitation, and communication skills