Investigation Specialist

Work Schedule

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, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

When you’re part of Thermo Fisher Scientific, you’ll do challenging 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 $20 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.

Position Summary:

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 basis

• Process improvements, cycle time adherence and value stream mapping

• Reduction of recurring DRs (data analysis support to be provided by QA team)

• Positive cultural transformation

• Continued 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 matrix

• Tracking 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.