FreshRemote.Work

QA Specialist

Durham, United States

Protecting our tomorrow

Would you like to be part of a multinational company working in a global team to ensure a high standard of quality and improve our Quality Management System (QMS)? Are you passionate about driving continuous improvements and streamlining lean processes in QA?

Great! We are looking for a QA Specialist located in North Carolina.

Boost our team

  • We are supporting Good [X] Practice (GxP) activities in the US
  • Join the Global Quality Systems (GQS) Team of 12 employees including 7 QA Specialists
  • Enjoy working fully remote
  • This position is for part-time, 30 hours per week

Your Impact
Our vaccines make a real difference to people, and no matter your role we all contribute to protecting lives every day. Your task will include:

  • Project Lead for assigned Continuous Improvements (40% of the time)
  • Process Manager for assigned processes in the Training and Records Management Team (20%)
  • Hosting the Global Process Stakeholder Meetings (10%)
  • Participant in validation activities related to Veeva Quality (10%)
  • Establish and maintain governance documents (SOPs/WIs etc.) (10%)

You will report to the Head of the GQS team.

Are you our next pioneer?
Succeeding with our vision of becoming one of the largest pure-play vaccine companies in the world is no walk in the park, and that is why we need people like you who are determined to make it happen and have the following qualifications:

  • A minimum of 5 years of professional experience in a cGMP environment and with QMS processes, Records Management, and Data Integrity is required
  • Must have prior experience in Pharmaceutical/Biotech Industry
  • Excellent project management skills and experience in leading continuous improvement initiatives
  • Excellent skills in MS Office and QMS systems (Veeva Vault as a plus)
     

As this role involves working with a wide range of stakeholders, it is essential to be open-minded and actively listen to their input and ideas. You should be able to collect, analyze, and evaluate feedback to identify the best ways to improve the QMS. A strong understanding of GMP and a mindset aligned with these principles is crucial. The role also requires openness to collaborate effectively with people from diverse cultural backgrounds, demonstrating cultural sensitivity and adaptability.

Why join us?

  • Join a global team and collaborate with stakeholders across multiple departments and locations
  • You will be part of a global and fully integrated vaccine company committed to improving and saving lives through innovative vaccines
  • Make …
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