QC Reviewer - FSP, client dedicated

myGwork - LGBTQ+ Business Community; Stevenage; Hybrid; GBP 30,000 - 45,000; Full time

Job summary

A leading company in the biotechnology sector is seeking a QC Reviewer to ensure data integrity and support key workflows in Stevenage. This role offers the opportunity for growth within a diverse team, ensuring compliance in a fast-paced environment. Applicants should have a scientific background and previous experience in a pharmaceutical context.

Qualifications

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

Responsibilities

• Verify data against source systems.
• Manage data associated with CMC statistics workflows.
• Communicate discrepancies to involved parties.

Skills

Attention to detail

Quality focus

Communication skills

Proactive attitude

Education

BSc/MSc in Scientific Discipline

Job description

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This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and 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 have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ 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 in support of key workflows which includes data checking and CMC Statistics data management

Responsibilities

• Verify data in the BYOD data product matches data in source systems
• Verify data in source documents matches data matches raw data
• Identify gaps where data inconsistencies are identified
• Manage the data associated with CMC statistics workflows
• Provide consolidated tables generated from multiple data sources
• Communicate any discrepancies with the parties involved and take steps to correct them in a timely manner.
• Performing a check of the current data to ensure that it is accurate, consistent, and reflects its intended purpose.
• Assesses procedures for accuracy, simplicity, and practicality and influences changes as appropriate
• Builds and maintains good working relationships with internal and external partners
• Manages issues and risks identified in area of responsibility
  
  

The successful candidate will have

• BSc/MSc in a Scientific Discipline
• Previous experience in a pharmaceutical manufacturing environment
• Previous experience in a comparable role, including prior experience with data review, data verification and data management
• Knowledge of GMP/GxP regulations
• Strong attention to detail with a focus on quality
• Fluency in Enlgish with strong communication skills (oral and written)
• Proactive attitude with willingness to learn and adapt to meet business needs
  
  

Our 4i Values

Integrity – Innovation – Intensity – Involvement

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

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Administrative

• Industries

  Biotechnology

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