Quality Operations Technical Specialist- On Site
Quality Operations Technical Specialist- On Site
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 implementand 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:
- Bachelors 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 219000 square meters our campus is home for more than 1000 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 OFCCPhere
About Sartorius
Sartorius 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.
Experience:
Unclear Seniority
Employment Type
Full-Time
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved