QC Reviewer - FSP, client dedicated

Thermo Fisher Scientific Inc.; Stevenage; Hybrid; GBP 30,000 - 45,000; Full time

Job summary

A leading contract research organization is hiring a QC Reviewer in Stevenage. The role focuses on data management and requires a BSc/MSc in a scientific discipline and experience in a pharmaceutical setting. Joining our team means becoming part of our mission to make the world healthier and safer while embracing our values of Integrity, Innovation, Intensity, and Involvement.

Qualifications

• Experience in pharmaceutical manufacturing environment.
• Experience in data review, verification, and management.
• Knowledge of GMP/GxP regulations.

Responsibilities

• Verify data accuracy and consistency across systems.
• Identify and manage data discrepancies.
• Communicate with relevant parties regarding data issues.

Skills

Attention to detail

Data management

Communication

Education

BSc/MSc in a Scientific Discipline

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and a world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we offer a functional service provider solution, which is an outstanding partnership that allows our customers to leverage our staff's expertise while providing employees with the opportunity to gain direct onsite experience at a pharmaceutical or biopharmaceutical company, all while maintaining full-time benefits.

The role of QC Reviewer will ideally be based fully or partially at our client's site in Stevenage; however, remote working may be considered.

As a QC Reviewer within our client-dedicated team, you will provide data management support for key workflows, including data checking and CMC Statistics data management.

Responsibilities:

1. Verify that data in the BYOD data product matches data in source systems.
2. Verify that data in source documents matches raw data.
3. Identify gaps where data inconsistencies are found.
4. Manage data associated with CMC statistics workflows.
5. Provide consolidated tables generated from multiple data sources.
6. Communicate discrepancies with relevant parties and take corrective actions promptly.
7. Perform checks to ensure data accuracy, consistency, and proper reflection of its purpose.
8. Assess procedures for accuracy, simplicity, and practicality, and suggest improvements as appropriate.
9. Build and maintain good working relationships with internal and external partners.
10. Manage issues and risks within your area of responsibility.

The successful candidate will have:

1. BSc/MSc in a Scientific Discipline.
2. Previous experience in a pharmaceutical manufacturing environment.
3. Experience in data review, verification, and management.
4. Knowledge of GMP/GxP regulations.
5. Strong attention to detail and focus on quality.
6. Fluency in English with strong communication skills (oral and written).
7. A proactive attitude and willingness to learn and adapt to business needs.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values and wish to help accelerate the delivery of safe and effective therapeutics for urgent health needs worldwide, submit your application – we’d love to hear from you!