Quality Assurance Specialist

JR United Kingdom; Cambridge; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading global development organization seeks a Quality Specialist to ensure compliance with GMP and regulatory standards. This role involves reviewing clinical batch records, managing documentation accuracy, and collaborating with teams to support the delivery of life-saving treatments. The ideal candidate will have a Bachelor’s degree in a scientific discipline and possess strong attention to detail and communication skills.

Qualifications

• Bachelor's in Chemistry, Biology, or Pharmacy required.
• Strong attention to detail, organizational skills, and excellent communication are essential.
• Ability to work independently and manage multiple priorities.

Responsibilities

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

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.