Quality Assurance Specialist

Smart4 Sciences; Alton; On-site; GBP 42,000 - 60,000; Full time

Job summary

Smart4 Sciences in Alton is seeking a Quality Assurance Engineer/Specialist to ensure compliance across production and customer operations. The role involves coordinating audits, leading investigations into non-conformities, and managing change controls to uphold GMP standards.

You will review deviations, support new product introductions, and liaise with customers while representing the QA function. A degree in science/engineering and ISO13485 experience are desirable.

Qualifications

• Qualified internal auditor with hands-on QA experience in GMP-regulated environments.
• Strong knowledge of GMP, ISO13485 and quality systems.
• Experience applying problem-solving techniques to identify root causes and implement CAPAs.

Responsibilities

• Coordinate and manage the internal audit programme with planning, execution, reporting and CAPA follow-up.
• Lead investigations into non-conformities and quality issues, implementing effective corrective actions.
• Manage Change Control to ensure regulatory and operational compliance.
• Investigate customer quality issues and complaints with timely corrective actions.
• Review deviations and allocate actions for timely closure.
• Support new product introduction projects through line trials and inspections.

Skills

Internal auditor

Quality Assurance

GMP knowledge

Root cause analysis

QA collaboration

Education

Degree in science/engineering/manufacturing

ISO13485 knowledge

Tools

Change Control

CAPA

Deviations review

Job description

Quality Assurance Engineer/Specialist - Alton - Office Based

I am currently working with a leading CDMO manufacturing business based in Alton, supporting the pharmaceutical, medical device, cosmetics, and nutritional sectors. This is an excellent opportunity for an experienced Quality Assurance professional to join a fast-paced environment and contribute to ensuring compliance across production and customer operations.

Key responsibilities for the Quality Assurance Engineer/Specialist

• Coordinate and manage the internal audit programme, including planning, execution, reporting, and follow-up of corrective actions.
• Lead investigations into non-conformities and quality issues, applying problem-solving techniques to identify root causes and implement effective CAPAs.
• Manage the Change Control process to ensure regulatory and operational compliance.
• Investigate customer quality issues and consumer complaints, providing timely responses and corrective actions.
• Review and complete deviations, allocating actions to relevant teams and ensuring closure.
• Support new product introduction projects, including line trials, capability studies, and product inspections to meet customer specifications.
• Oversee QA validation team operations, including workload allocation and performance reviews.
• Review and sign off packing specifications and support with PQR reporting.
• Liaise with customers and attend meetings to represent the QA function.

Requirements for the Quality Assurance Engineer/Specialist

• Qualified and experienced internal auditor.
• Strong background in Quality Assurance within GMP-regulated environments (pharma, medical device, cosmetics).
• Good knowledge of quality improvement tools and problem-solving techniques.
• Ability to manage multiple priorities, work under pressure, and communicate effectively across all levels.
• Degree in science, engineering, or manufacturing discipline desirable.
• Experience with ISO13485 and GMP compliance advantageous.