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Quality Assurance Specialist

JR United Kingdom

Basildon

On-site

GBP 30,000 - 45,000

Full time

3 days ago
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Job summary

A global organization seeks a motivated Quality Specialist to contribute to a pivotal team. This role involves reviewing clinical batch records and ensuring compliance with regulatory standards in the production of life-saving medicinal products. Candidates will leverage their scientific background and detail-oriented nature to manage documentation and issue resolutions, ensuring quality in healthcare processes.

Qualifications

  • Degree in scientific discipline (Chemistry, Biology, or Pharmacy) is essential.
  • Strong attention to detail and organizational skills required.
  • Prior experience in QA or GMP environment preferred.

Responsibilities

  • Review clinical batch records for GMP compliance.
  • Compile data packs for QP release.
  • Collaborate with clinical supply chain teams.

Skills

Attention to detail
Organizational skills
Communication
Interpersonal abilities
Ability to work independently
Management of multiple priorities

Education

Bachelor’s degree in Chemistry
Bachelor’s degree in Biology
Bachelor’s degree in Pharmacy

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.
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