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Job ID :
60958BR
Location :
US - Maryland - Rockville
:
Job Description

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.


Fisher BioServices, part of Thermo Fisher Scientific, 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. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. We offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. http://www.fisherbioservices.com/

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.

Responsibilities:

  • Applies current Good Manufacturing Principles (cGMP) in all areas of responsibility.
  • Develops and administers GMP training.
  • Assisting QA Manager with the Supplier Quality Management program.
  • Monitoring internal and supplier audits through a Quality Management System (TrackWise).
  • Helping QA Manager coordinate and execute the Internal Audit program.
  • Assists with and follows-up on non-conformances, investigations, complaints, 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 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.
  • Supports and assists on regulatory and client audits.
  • Demonstrates and promotes the company vision.

Minimum Qualifications:

  • Bachelor degree (B.A./B.S.) is strongly preferred
  • 2-5 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)
  • Training background: Experience with development and administration of GMP training
  • Auditing background: Experience internal auditing and supplier auditing
  • 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.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. Apply today at 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.




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.
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