QA Specialist- Onsite

Posted 12 Days Ago
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Yauco
Senior level
Biotech
The Role
The QA Specialist will manage the quality systems by drafting SOPs, supporting process improvements, ensuring compliance with GMP regulations, and addressing deviations. The role requires collaboration with teams to resolve issues and maintain databases for audits and investigations.
Summary Generated by Built In

The QA Specialist will be responsible for administering quality systems using basic skills and knowledge of appropriate procedures, methods and techniques, as well as applicable current good manufacturing practice and customer requirements. The holder of this position will help to ensure implementation, maintenance, and improvement of the quality system.

Grow with us- Your Responsibilities & Tasks:

  • Draft and review Standard Operating Procedures (SOPs)
  • Support ongoing process improvement endeavors
  • Maintain and ensure applicable regulatory and internal QMS compliance for staff training/personnel files, master schedule, deviation trending/tracking, etc.
  • Provide support for internal and sponsored projects including reviewing protocols and reports
  • Work collaboratively with staff responding to and resolving deviations and incidents
  • Follow through on corrective and preventative actions from deviations and audit observations
  • Maintain databases for investigations, audit observations and CAPA

What will convince us- Qualification & Skills:

  • Bachelor's Degree in Science, Engineering or related field. 5+ years in a GMP regulated manufacturing (preferred).
  • Minimum of 3 years of experience in related position is required
  • Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems
  • Knowledge of quality systems and product/process lifecycle management within a manufacturing environment
  • Proficient computer skills required
  • Excellent communications skills both written and oral, including ability to navigate potentially challenging situations both internal and external to the business during the coordination of QMS programs
  • Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively in order to expedite the successful execution of assigned work
  • Efficient organizational skills, including the ability to manage multiple processes and priorities effectively
  • Good command of spoken and written English

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 OFCCP here

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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. 
www.sartorius.com/careers

The Company
HQ: Göttingen
9,059 Employees
On-site Workplace
Year Founded: 1870

What We Do

Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing.

We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide.

With innovative laboratory instruments and consumables, the our Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes.

The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically.

Based in Göttingen, Germany, Sartorius also has a strong global reach with around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies.

In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe.

Join our team, partner or collaborate with us.

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