GMP Investigation & CAPA Specialist

Thermofisher Scientific; Waltham (MA); On-site; GBP 45,000 - 65,000; Full time

Job summary

Thermo Fisher Scientific is seeking an Investigation Specialist to join our GMP-driven manufacturing operations in the United Kingdom. You will complete deviation investigations, implement CAPAs, update SOPs, and support change controls to ensure product quality and regulatory compliance.

You will collaborate across operations, contribute to risk-based decision making, and develop documentation, with emphasis on procedural writing, training needs, and maintaining strict housekeeping and safety

Qualifications

• Proficiency in GMP principles and guidelines.
• Excellent technical writing and documentation skills.
• Strong interpersonal communication and collaboration abilities.
• Ability to make sound risk-based decisions in a manufacturing setting.
• Experience driving process improvements in GMP environments.

Responsibilities

• Complete deviation investigations and write deviation records.
• Implement CAPAs and change control actions.
• Revise, improve, and simplify SOPs as needed.
• Maintain focus on key performance metrics in operations.
• Highlight training needs to managers and influence learning across the organization.
• Apply PPI tools to drive process improvements.
• Provide technical support in writing BSTCC.
• Update and develop SOPs and support BMR updates with input.
• Develop department-specific Change Controls and present to the committee.

Skills

GMP compliance

Technical writing

Interpersonal skills

Risk-based decisions

Process improvement

Tools

BSTCC

Job description

Thermo Fisher Scientific is seeking an Investigation Specialist to join our GMP-driven manufacturing operations in the United Kingdom. You will complete deviation investigations, implement CAPAs, update SOPs, and support change controls to ensure product quality and regulatory compliance.

You will collaborate across operations, contribute to risk-based decision making, and develop documentation, with emphasis on procedural writing, training needs, and maintaining strict housekeeping and safety