Quality Assurance Specialist

JR United Kingdom; Cardiff; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading global healthcare company is seeking a Quality Specialist to join their Development Quality team. This role involves ensuring compliance with GMP for clinical trial products and offers significant opportunities to contribute to the delivery of important medicinal products. Candidates should possess a scientific background and strong attention to detail, and will play a key role in maintaining compliance and quality standards throughout clinical operations.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy.
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and work independently.

Responsibilities

• Perform final review of clinical batch records for GMP compliance.
• Compile data packs for Qualified Person release.
• Collaborate with global supply chain and manage issue resolution.

Skills

Attention to Detail

Organizational Skills

Communication

Interpersonal Abilities

Independence

Education

Bachelor’s degree in a scientific discipline

Job description

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An exciting opportunity is available for a motivated and detail-oriented Quality Specialist to join a Global Development Quality team. This role offers exposure to a wide range of investigational medicinal products, from small molecules to advanced immunotherapies, contributing directly to the delivery of life-saving treatments to patients.

Key Responsibilities:

• Perform final review of clinical batch records to ensure compliance with GMP and regulatory filings.
• Compile and approve data packs for Qualified Person (QP) release.
• Collaborate with global clinical supply chain teams and manufacturing sites (internal and external).
• Manage issue resolution and ensure timely documentation and communication.
• Maintain high standards of accuracy and compliance throughout the review process.

Qualifications & Skills:

Required:

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy).
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal abilities.
• Ability to work independently and manage multiple priorities.

Preferred:

• Prior experience in a QA or GMP-regulated environment.
• Familiarity with clinical manufacturing and regulatory compliance processes.