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Investigation Specialist
On-site in Swindon·Full-time·Added yesterday (last checked 10 Nov)
163 open roles
Our summary
- Work mode
- On-site, Swindon
- Contract
- Full-time
Skills
Requirements
Nice to have
- Substantial experience in pharmaceutical manufacturing, particularly sterile filtration and liquid filling.
- Skills in mechanical and software operations or working knowledge.
- Experience in new facility/process start-up.
- Experience in lean/manufacturing process improvement.
Education & certifications
- Proficiency in GMP principles and guidelines is required.
- Understanding of the end-to-end manufacturing process.
- Proactive approach with a willingness to deliver against landmarks.
- Pragmatic approach to problem-solving.
- Demonstrable ability to make sound risk-based decisions.
- Excellent interpersonal skills and the ability to challenge behaviors appropriately.
- Technical writing skills.
- Good time management skills.
The role
What you'll do
- Complete Deviation investigations and write Deviation records.
- Implement CAPAs and change control actions.
- Revise, improve, and simplify SOPs as needed.
- Maintain focus on positive critical metric positions in operations.
- Highlight training needs to managers and influence company-wide learning.
- Apply PPI tools to drive process improvements.
- Support RAPID Investigation Operations.
- Provide technical support in writing BSTCC.
- Update and develop SOPs.
- Support BMR updates with technical input.
- Develop department-specific Change Controls and present them to the committee.
- Update and present departmental important metric matrices.
- Track improvements and prevent troubleshooting solutions for key collaborators.
- Maintain required housekeeping standards at all times.
How you'll work
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Position Summary
Join Thermo Fisher Scientific Inc. as an Investigation Specialist and become part of a remarkable team! This is an outstanding opportunity to work within a global leader in scientific services, contributing to exceptionally innovative and collaborative projects. With our organization, you'll be part of an ambitious company that values performance, quality, and innovation. We strictly determine the needs of our clients and successfully implement solutions that make a significant impact on the world.
Procedures and Documentation
- Collaborate with employees across operations to draft, improve, and update SOPs and work instructions.
- Implement GMP updates and evaluate the necessity for adjusting procedures and documentation.
- Contribute to BMR improvement by capturing findings and incorporating them into the BMR.
Ehs
- Understand emergency procedures and follow safe systems of work.
- Ensure compliance with environmental, health, and safety rules and instructions.
- Promptly report and investigate all accidents, near misses, and breaches of rules.
Hiring process
Online application
Interview with a Recruiter
With a Recruiter · Phone call
Text, phone/video, or onsite interview with a Recruiter, 15-60 minutes.
Interview with Hiring Manager
With a Hiring Manager · Phone call
Phone/video or onsite interview with the Hiring Manager, 30-60 minutes.
Interview with the hiring team
With 1-5 members of the hiring team · In person
Onsite or video interview with 1-5 members of the hiring team.
- The online application should take less than 15 minutes.
- Candidates with special requirements can contact the company for accommodations during the steps.
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