Job Description

When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.

Thermo Fisher Scientifics Mission is to enable our customers to make the world healthier, cleaner and safer, and the global coronavirus (COVID-19) outbreak is a powerful reminder of the importance of that Mission. In fact, Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak. Our efforts have been particularly focused in supporting analysis of the virus, diagnosis, personal protection, and ultimately helping in the development of new therapeutics and vaccines.

Location/Division Specific Information

This position is located at the Rochester location, 75 Panorama Creek Dr., Penfield, NY 14625 within the Laboratory Plastics Essentials (LPE) Business Unit of the Laboratory Products Division (LPD).

How will you make an impact?

We are looking for a self-directed highly-motivated Quality Specialist with experience working with a Quality Management System (QMS) to ensure compliance to both regulatory requirements and International Organization for Standardization (ISO) standards as applicable. Under the direction of the Manager, Quality Systems this position is responsible for managing the change management processes as defined by the applicable quality system documents; working with training and the trainees to ensure the effective deployment of training curriculum to the site based on those aforementioned changes; and analyzing and reporting quality system data to Quality Assurance, Operations, and R&D teams who are responsible for monitoring its performance and ensuring that quality requirements for products, processes, or system are being fulfilled.

What will you do?

* Acts as a subject matter expert regarding the change management processes. As the subject matter expert, provide information to the site to ensure consistent application of those associated quality processes.
* Supports the implementation of submitted product, process, or system changes by facilitating change management activities with cross-functional team members and stakeholders, as applicable, and ensuring compliance to current regulations, standards, and quality system documents. This is accomplished by using and following the change control approval matrices; processing and following through with the approvals and tracking of changes; and escalating if changes are not reviewed and approved in a timely manner.
* Works with training and the manager and trainee to ensure the effective deployment of training curriculum to the site. Serve as a change control and training administrator including password setup, general training, and usage questions.
* Supports QMS activities and processes by working with others to define the reporting characteristics/criteria and running reports.
* Coordinates applicable review boards in which those reports are reviewed.
* Complies with required quality, safety, and operation/distribution quality system documents - such as our quality manual and policy, good documentation practices, plant safety commitments, general safety requirements, personal protective equipment program, and good manufacturing and distribution practices - as applicable.
* Performs other duties as needed.

How will you get here?

Education/Experience:

* Associates Degree in related field, or consideration of an equivalent combination of education and experience. Bachelors degree in related field preferred.
* Working experience with a QMS (Quality Management System).
* Working experience with regulatory requirements and/or International Organization for Standardization (ISO) standards preferred.
* Focus and carry out tasks in a timely and accurate manner.
* Well organized and structured and detail-oriented.
* Ability to work effectively and build and maintain collaborative relationships with individuals and teams across functional boundaries at all levels of the organization.
* Ability to communicate effectively, both verbally and in writing, with internal customers.
* Ability to provide quality specific training and guidance to the organization.
* Working knowledge of ERP Systems (SAP and/or E1), CAPA (TrackWise), Document Control (MasterControl and/or Agile), and Training (MasterControl and/or SuccessFactors) is preferred.
* Ability to use all of the following PC applications: Microsoft Word, Excel (basic data analysis), and PowerPoint. Microsoft Power BI is preferred.

What Thermo Fisher Offers to Employees:

* Medical, Dental, and Vision benefits effective on first day of employment
* Paid Time Off Eligible to accrue up to 120 hours of Paid Time Off (PTO), pro-rated based on start date
* Paid Holidays
* 401(K) Retirement Plan Company Matching Contribution up to 6%
* Shift Premium for night shift employees

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $22 billion and approximately 75,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer.

We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.