Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Investigation Specialist

Position Summary:

When you’re part of Thermo Fisher Scientific, you’ll do exciting work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

This role supports processes within operations in the implementation and delivery of good manufacturing processes. This role is a part of the Investigation Team for Operations. This team is responsible for supporting the technical challenges, improvements, investigations for production and sharing standard processes with other teams.

Team deliverables:

Reduction of the Quality critical metrics overdue backlog (DRs, CAPA, CC, DI etc) and ongoing management of Quality important metrics on a timely basisProcess improvements, cycle time adherence and value stream mappingReduction of recurring DRs (data analysis support to be provided by QA team)Positive cultural transformationContinued Process Verification

This role supports processes within the operation department in the implementation and delivery of good manufacturing practice from a technical perspective.

Key responsibilities:

Complete Deviation investigation and writing Deviation records.Implement CAPAs and change control actions.Revise, improve and simplify SOPs as needed.Maintain focus on a positive critical metric position in operations.Highlight training needs to managers as they arise and influence Operations wide learning.Utilise PPI tools to drive process improvements.Support RAPID Investigation Operations.Provide technical support in writing:-BSTCC-Support deviation investigations-Update and create SOP-Support BMR updates with technical input-Create relevant department specific Change Controls, and present to committee.Update and present departmental important metric matrixTracking improvements, preventing troubleshooting solutions to key collaborators.Maintaining required housekeeping standards at all times.

Procedures and other documentation:

Work with employees across the operations to draft, improve and update SOPs, work instructions and other documentation, checking their application in the operational phase.Act on the updates to the GMP requirements and assess the need to update procedures another documentation.Contribute to BMR improvement by capturing findings, checking their application in the operational phase, and then incorporating them into the BMR.EHS:Understand emergency procedures and follow safe systems of work.Ensure compliance with environment, health and safety rules, signage, and instructions always.Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Minimum Requirements/Qualifications:

Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.’Understanding of the end-to-end manufacturing process.Proactive approach to work, with a willingness to do what needs to be done to deliver against landmarks.Pragmatic / common sense approach to problem solving.Demonstrable ability to make sound risk-based decisions.Excellent interpersonal skills with the ability to appropriately challenge other’s behaviours.Technical writing skills.Good time management skills.

Desirable qualifications:

Substantial experience working in pharmaceutical manufacturing, with knowledge of sterile filtration, liquid filling components bulk provider manufacturing.Skills for, or working knowledge of mechanical and software operation.Experience of new facility/process start-up.Experience in lean/removal of non-value add from documentation and manufacturing processes desirable. 

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

We offer a wide range of flexible benefits in addition to competitive salaries which include pension and healthcare. Does this sounds like a good match for your skills and experience? If so we'd love to hear from you!