Quality Operations Technical Specialist- On Site

Sartorius

  • Yauco, PR
  • Permanente
  • Tiempo completo
  • Hace 1 mes
The Quality Operations Technical Specialist provides support to the different quality aspects of Cell Culture Media products, for the smooth functioning of the QA operations process and to maintain high-quality product standards.Grow with us- Your Responsibilities & Tasks:
  • Manage and support Customer Audits, technical visits, customers’ requests, and complex investigations/complaints
  • Support projects, including implementation or transfers of new products and/or new manufacturing lines
  • Implementation of changes, including material changes
  • Address suppliers' issues in collaboration with global teams
  • Connection with Regulatory partners
  • Maintenance of the Quality Management System
  • Support, implement, and monitor ISO 13485 certification
  • Support the stabilization at Yauco CCM facility for powder and liquid
  • Identify areas for improvement in the QA operations process and propose solutions
  • Keep effective communication with quality, manufacturing, engineering and Supply Chain teams.
  • Driven Continuous improvement
Qualifications and skills:
  • Bachelor’s degree in chemistry (preferred), Biotechnology, Microbiology, Biology, Chemical engineering, or another Technical Area.
  • 8+ years' experience in regulated industry or a minimum of 3 years of experience in Quality (preferred).
  • Fully bilingual (Spanish and English), both spoken and written
  • Ability to work with people from different backgrounds (education, culture, etc)
  • Proven experience in quality assurance or operations roles.
  • Strong knowledge of quality principles and methodologies.
  • Familiar with ISO 9001, ISO 13485, GMP, EP, FDA
  • Proficiency in investigation techniques applicable to non-conformances and/or complaints
  • Proficiency in Technical Writing
  • Basic Statistics knowledge: proficiency in Minitab is a plus
  • Ability to work independently and as part of a team.
  • Attention to detail and analytical thinking abilities.
  • Effective Prioritization, Planning and Time Management: Must be able to organize and plan workload on several projects concurrently to meet deadlines.
  • Experience with project management tools and techniques is a plus.
  • Experience with Cell Media is a plus.
What will convince us- Qualification & Skills:
  • Paid vacation and sick leave
  • 14 paid holidays annually
  • Impressive campus: Located on 219,000 square meters, our campus is home for more than 1,000 employees
  • We offer an open-office concept, a spacious outdoor area, conference areas and a development center
  • Medical, Dental and Vision insurance along with Company Retirement Plan
  • On-site cafeteria and coffee shop
  • On-site occupational health offices including Laboratory Services & Doctors
Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.Please view equal employment opportunity posters provided by OFCCPAbout SartoriusSartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.Join our global team and become part of the solution. We are looking forward to receiving your application.

Sartorius