Job Description

When you2019re part of the team at Thermo Fisher Scientific, you2019ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have a real-world impact, and you2019ll be supported in achieving your career goals.

How will you make an impact?

Responsible for leading department quality investigations to determine root cause and CAPA. Proactively leads quality and continuous improvements for the department.

What will you do?

* Responsible for conducting investigations of Facility & Utility related deviations affecting batches, preps, lots and equipment to ensure all cGMPs, SOPs, and customer requirements are met.
* Responsible for leading the RAPID process including initial response, containment, root cause investigation and determining appropriate CAPA.
* Responsible for leading RFM huddle process to achieve timely deviation and CAP closure to meet departmental goals.
* Proactively drives quality improvements to achieve departmental RFT and quality compliance goals.
* Participates in inspection readiness activities and may also be involved in audits and inspections by regulatory agencies.
* Models effectiveness and constructive communication and interactions with technical departments, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
* Requires a passion for problem solving, attention to detail, good organizational skills, a sound understanding of cGMPs and Manufacturing/Packaging.
* Requires interaction with the operational personnel, QA GMP Services, Process Engineers, Records/Release, Quality Control, QA Regulatory, Engineering and Clients. Position requires flexibility at times to complete interviews/investigations with night and end of week shifts.
* Escalates critical events and investigation findings to Production and Quality Assurance Management.
* May represent the utilities department on various project teams, such as, validation, engineering phase review meetings, and daily department communication meetings. May also assist in developing and maintaining various quality and training systems and programs.

How will you get there?
Education:

* Bachelors' Degree in engineering or related field preferred. High School Diploma Required.

Experience:

* 1-3 years experience in manufacturing or power plant environment.
* Quality, continuous improvement, process and manufacturing investigation and technical writing experience is desired.

Competencies:

Incumbent must be able to understand cGMP's requirements. Must have sound problem solving skills and good verbal/written communication skills. Experience writing technical reports is desired. Must be able to manage and prioritize daily tasks with minimal supervision. Must be capable of using Microsoft Office Word, Excel, and PowerPoint. Must be able to learn and navigate through investigation, quality and ERP systems. Must have independent decision making capabilities and ability to think conceptually and understand impact of decisions. Expected to be hard working and productive in an autonomous environment. Very good conflict resolution and negotiation skills. Good organization skills resulting in the ability to be self-directed and manage multiple projects. Emerging Leadership and mentoring skills. Expected to have respectful interactions with individuals with diverse views or backgrounds. Have flexibility to work various shifts times if needed to complete work content.

Physical Requirements:

Able to enter production areas (PPE required) to support quality investigations.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be constructed as an exhaustive statement of duties, responsibilities or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experience for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.