Job ID :
US - Maryland - Rockville
Job Title: Quality Specialist III
Location: Rockville, MD
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.
Join the Fisher BioServices team as a Quality Specialist in Rockville, Maryland. Fisher BioServices is the industry leader in the management of critical biological materials to support the advancement of cell therapy, GMP biologics, and population-based public health research.
Applies current Good Manufacturing Principles (cGMP) in all areas of responsibility.
Coordinates and supports the execution of the Internal and Client Audit program
Assists with and follows-up on non-conformances, investigations, complaints, CAPAs, etc.
Assures that issues are resolved in a timely manner and corrective actions/preventive actions (CAPA) are implemented and monitors effectiveness to prevent reoccurrence.
Evaluates and develops techniques / trainings designed to maintain awareness of SOP's, cGMP's and clinical requirements.
Extensively interacts with direct functional teams (Operations, Client Services, etc.) to resolve quality issues.
Performs quality review of procedures, work instructions, batch records, etc. prior to implementation and quality review of executed records.
Support the administration of the Learning Management System and overall training program
Demonstrates and promotes the company vision.
Bachelor degree (B.A./B.S.) is strongly preferred
3-5 years Quality Assurance/ Quality Control experience in a cGMP environment
Previous experience in the Pharmaceutical, Medical Device, and/or Biotechnology industries
Experience with Quality Management Systems (Change control, deviations, complaint management, CAPA, documentation management, supplier quality, internal audits)
Understanding of Six Sigma, Lean, Practical Process Improvement (PPI), etc.
Must have a sound understanding of cGMP's and SOP's.
Must have understanding of validation, calibration, preventive maintenance, electronic records, among others.
Possess strong written, verbal and interpersonal communication skills and work independently as well as in close collaboration with others.
Excellent analytical skills and ability to synthesize trending data into meaningful information for the organization.
Demonstrated attention to detail and ability to solve problems and communicate issues.
Ability to work on multiple projects with competing deadlines.
Willingness to travel 10-20%
Demonstrate Thermo Fisher Scientific values Integrity, Intensity, Innovation and Involvement.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here 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.
Thermo Fisher Scientific Inc.