Job Description

　　Quality Control Manager Compliance and Continuous Improvement

　　When you’re part of the team at Thermo Fisher Scientific, you’ll 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 you’ll be supported in achieving your career goals.

　　Location/Division Specific Information:

　　St. Louis/Quality Control

　　How will you make an impact?

　　This job will be responsible for the Quality Control Compliance and Continuous Improvement team which performs GMP analytical investigations and analytical data review team in order to support the site’s high paced manufacturing environment. In addition, you will lead individuals focused on QC compliance and continuous improvement. A key opportunity in this role will be identifying trends and implementing systems to remediate negative trends and improve efficiency.

　　What will you do?

　　Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; encouraging 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.

　　Supervise efficiency and provide priorities for the team.

　　Review or manage QC investigations, ensuring identification of root cause and adequate CAPA.

　　Manage QC Data Review team

　　Provide support to the QC Testing and Support teams, including supporting investigations, compliance trending and communications of trends and needed actions, testing data review, audit response management, and continuous improvement projects in QC.

　　Train new hires on department processes, procedures and tools.

　　Interact with auditors/clients during visits and tours.

　　Performance management for staff.

　　Review and approval of documentation generated by the group.

　　Effectively communicate with peers, manufacturing, QA, and QC staff, to resolve technical issues and direct activities.

　　Provide support to site Safety initiatives.

　　Other job duties as assigned.

　　How will you get here?

　　Bachelor’s degree in biological science or related field required

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

　　Minimum of five years’ experience in pharmaceutical industry quality control/analytical or similar experience.

　　At least two years supervisory/leadership experience within the pharmaceutical industry.

　　Experience in performing investigations is required. Including utilization of problem solving tools (RCA tools including 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis, etc.) with demonstrated success.

　　Knowledge of QC analytical techniques is preferred (HPLC, UPLC, CE, CGE, ELISA, Microbial, Bioassay Testing, etc)

　　Communicating and Responding during client and regulatory inspections.

　　Experience working in cross functional teams and getting results to what is best for the entire organization

　　Knowledge, Skills, Abilities

　　Ability to inspire and champion innovation, teamwork, clarity and team effectiveness.

　　Technical experience and judgment is called upon during investigation and daily interpretation of analytical results.

　　Must possess strong investigational skills to determine root cause and identify and implement effective correction actions.

　　Ability to manage timelines and coordinate work schedules of employees.

　　Ability to make recommendations based on trends and trend analysis.

　　Ability to work in a fast paced environment with the ability to prioritize effectively to meet timelines.

　　Knowledge and ability to apply lean and/or operation excellence with the lab

　　At Thermo Fisher Scientific, each one of our 80,000 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!

　　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.

　　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.