Thermo Fisher Scientific Supervisor, QA Operations (Off Shift) in St. Louis, Missouri

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 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.

Location/Division Specific Information

This is a supervisory role, reporting to the Manager of QA Operations at the Thermo Fisher St. Louis site. This is an off shift position to cover production activities. The typical schedule is Monday through Friday, 3:30p - 12:00am, but may require occasional weekend work. The St. Louis site is part of the biologics division.

How will you make an impact?

The QA Operations group members are specialists in deviation prevention. This team executes QA on-the-floor activities, batch record review, and approval of deviations and standard operating procedures (SOP). All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

What Will You Do?

  • Supervise and mentor a team that works in the manufacturing areas when production is on-going. This team oversees activities from a quality perspective and answers QA-relevant questions / provide QA input in real-time.

  • Supervise team in the performance of suite and equipment changeover between client processes

  • Serve as QA approver for minor deviations, batch record revisions, SOP revisions, and other required site documentation. In addition, supervise team members who also complete these tasks.

  • Individuals in your group must be able to obtain buy-in and cooperation to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact and diplomacy with internal and external customers is essential.

  • Supervise team by ensuring that routine meetings are held to keep team abreast of personal performance and team metrics.

How Will You Get Here?

Education

  • BS/ BA in biology, biochemistry, chemistry or other science related field

Experience

  • A minimum of five (5) years of cGMP (or other highly regulated industry) experience

  • 3+ years of direct experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred

  • Fluent in managing batch record review for GMP manufacturing

  • Previous experience as a supervisor of staff

  • Demonstrated history of building teams and interdepartmental relationships

  • Experience in investigational writing software system is a plus (TrackWise) along with root cause analysis tools utilized in deviation investigations

  • Cleanroom manufacturing experience is a plus along with a comfort level with full ISO 5 and ISO 7 gowning requirements

  • Previous QA on the floor experience is a plus

  • Direct manufacturing experience is a plus

  • Tech transfer experience is a plus

Knowledge, Skills, Abilities

  • Knowledge of Quality practices and cGMP regulations and other international health authority guidelines

  • Demonstrated ability to make quality decisions is required.

  • Critical thinking with the ability to read, analyze, and interpret technical data

  • Solid time management and organizational skills

  • Analytical, problem solving, and basic math skills

  • Strong written and oral communication skills

  • Strong Microsoft Office skills (especially Word and Excel)

  • Must be able to read, write, and communicate in English

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling 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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.