Accelerate biotechnology

(part-time) QA Officer in US (Woburn, MA)

We are looking for a (part-time) QA Officer for our facility in Woburn MA, USA. The QA officer is responsible for the quality support in our development programs and performs all relevant activities related to product development and production of clinical trial material. As a QA Officer you will be mainly responsible for:

  • Maintain and support the quality management system
  • Document, Change, Quality/Safety Incident and CAPA Control
  • Review of study plans, study reports, memo’s, deviations and check on lab notebooks
  • Execute internal audits; follow up on audit observations during internal and customer audits
  • Support the supplier qualification program
  • Together with your QA colleagues you will ensure proper quality in customer projects.

You will join a stimulating group of international researchers in a very collaborative environment. This QA officer position reports to the Director QA/QP.

Your letter of motivation and CV should show that you have:

  • A Bachelor / Master degree in life science, biotechnology or related subject;
  • At least two years’ experience in a biotechnology or biopharmaceutical industry environment as QA Officer;
  • Experience with GLP/GMP
  • Experience with viral vectors and/or viral vaccines is a plus;
  • Experience with performing audits of facilities, systems or suppliers is a plus.
  • Knowledge of risk analyses and risk management

In the interviews it will be clear that:

You are enthusiastic and comfortable in a dynamic environment. You can work both in a team and individually. You communicate clearly at all levels; you can get your thoughts, ideas and knowledge across in a helpful way. You enjoy to train (process development and manufacturing) personnel in quality aspects. Your planning and organization skills allow you to have an overview of the necessary work and you are able to meet deadlines.

You can send your motivation letter and resume to Mrs. Ingrid van Aarle, HR Manager recruitment@bataviabiosciences.com

 

Application by agency or recruiters is not appreciated and will be rejected.