Job Description

When youre part of the team at Thermo Fisher Scientific, youll 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 real-world impact, and youll be supported in achieving your career goals.

Location/Division Specific Information

This position is located in Alachua, FL in the Quality Control Department of a dynamic gene and cell therapy contract development and manufacturing organization.

How will you make an impact?

The Specialist will work in the GMP compliant QC department to coordinate tech transfer activities to and from clients, other departments and/or other VVS sites. The position supports the team in the planning and adherence to plans for assay qualifications and validations. The communication between departments and with clients will ensure the transition of assays from development to the QC team for final product testing.

What will you do?

* Coordinate and communicate assay tech transfer priorities while tracking progress and delays so assay qualifications adhere to plan
* Review GMP material specifications and participate in the creation of QC sampling plans
* Assist QC team members in developing and closing out protocols and reports in addition to participating in client meetings

The Specialist will interact with QC team members to relay information from clients and other departments in a timely manner. The incumbent will technically interpret, write and review controlled documents and reports as well as review data produced by others.

How will you get here?

* Bachelors Degree in Life Sciences
* 3-5 years experience in a regulated GMP manufacturing or QC laboratory environment or equivalent
* Understanding of applicable regulatory requirements
* GMP documentation writing and review

Knowledge, Skills, Abilities

* Extensive knowledge of QC and GMP testing principles and procedures as applicable is preferred
* Electronic organizational skills using Microsoft Excel, Project or other planning tools
* Background in molecular biology, chemistry or virology

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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.