Quality Assurance Specialist

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

Job summary

A leading company in global development is seeking a Quality Specialist to join their team in Plymouth. This role involves ensuring compliance with GMP and regulatory standards, reviewing clinical batch records, and collaborating with manufacturing teams. Ideal candidates will have a scientific degree and strong attention to detail, contributing to essential life-saving treatments.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy or similar required.
• Strong attention to detail and organizational skills necessary.
• Prior experience in QA or GMP environment preferred.

Responsibilities

• Perform final review of clinical batch records for GMP compliance.
• Compile and approve data packs for Qualified Person (QP) release.
• Collaborate with global supply chain teams on compliance.

Skills

Attention to Detail

Organizational Skills

Communication

Interpersonal Abilities

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.