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

Pharmaceutical Services Group

How will you make an impact?

The Supervisor supports management of QA GMP Services, acting as a Quality resource to operations teams and aiding in resolution of events in the manufacturing site.

What will you do?

* Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

* Demonstrated ability to evaluate and resolve complex technical problems.

* Supervises and supports monitoring Operations and Quality departments to assure current Good Manufacturing practices, company SOPs, and product registrations are followed and maintained.

* Supervises quality team composed of seven to ten analysts, ensuring coverage and quality-on-the-floor.

* Assigns, reviews, and conduct investigations of manufacturing events, equipment, and facilities as per 21CFR requirements.

* Ensure appropriate scope of impact, CAPAs, and disposition recommendations.

* Responsible for performance management within the team, and represents QA during various meeting.

* Provide recommendations for approval or rejection of marginal batches and refer appropriate batches to Quality Operations Management for review. Latitude to determine sequence of work tasks to meet schedules.

* Task will include but not limited to:

* Weekly 1:1's with Analysts

* Investigation Status Tracking

* Team metric tracking/trending

* Weekly report outs to Quality Management

* Investigation Writing & Review/Approval

* CAPA Review/Approval

How will you get here?

Education

Bachelors degree in Chemistry or other relevant science, required

Experience

* Minimum of five (5) years of progressive experience within Quality in areas of QA, QC, Records/Documentation, Analytical Development, Process Engineer, Engineering or Manufacturing.

* One (1) year of experience in leadership role, preferable.

* Must have extensive knowledge of GMP's and excellent problem solving skills.

Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered

Knowledge, Skills, Abilities

* Knowledge in GMPs and FDA regulations

* Strong decision making skills.

* Technical and operational knowledge in Quality.

* The ability to handle multiple ongoing activities, and ability to prioritize tasks.

* Outstanding attention to detail and organizational skills.

* Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.

* Demonstrates ability to maintain a high degree of confidentiality.

* Requires discretion and independent judgment.

* Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.

* Highly effective verbal and written communication skills at all levels.

At Thermo Fisher Scientific, each one of our 75,000 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.