Quality Assurance Specialist

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

Job summary

A leading company is seeking a motivated Quality Specialist to join its Global Development Quality team. This role involves ensuring compliance with GMP standards through detailed reviews of clinical batch records, collaborating across teams, and maintaining high accuracy throughout the documentation process. The ideal candidate will possess a relevant scientific degree and exhibit strong organizational and communication skills.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy).
• Strong attention to detail and organizational skills.
• 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 (QP) release.
• Collaborate with global clinical supply chain teams.

Skills

Attention to detail

Organizational skills

Communication

Interpersonal abilities

Education

Bachelor’s degree in a scientific discipline

Job description

Social network you want to login/join with:

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.