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Quality Assurance Associate
The Quality Assurance Associate (QA Associate) actively participate in the Repligen ISO 9001 Quality Management System at our new OPUS Column production site in Breda. Our OPUS Columns are plug-in purification columns which saves time in the production process of pharmaceutical products.
The QA Associate will be responsible for the identification, review and approval of deviation investigations and Out of Specifications (OOS) results, root cause analysis and generate corrective actions to improve processes/systems.
The QA team will work closely with the manufacturing team to achieve quality product release.
- Works with subject matter experts, area managers and QA-Compliance personnel to properly convert documentation into the final written form.
- Prepares and publishes approved documentation in a timely manner to meet established deadlines (paper and electronic).
- Perform root cause analysis, assist with deviations and identification of corrective actions/process improvements.
- Maintains related database systems, logs and complete forms/records as required.
- Perform batch record review; to include review of production records, quality control records such as i.e.: monthly RO/DI, weekly Environmental Monitoring records, Out-of-Specifications (OOS) results and weekly/monthly logs.
- Assists in the implementation of QA policies and procedures.
- Organize and update training files as necessary to maintain compliance.
- Support internal and customer audits.
- Minimum a bachelor’s degree in Life Sciences, Biology, Pharmacy or other science related discipline.
- Minimum 3 years’ work experience within Quality Assurance in an ISO 9001 or GMP certified environment.
- Auditing experience is a plus.
- Experience and knowledge of IT software platforms that support Quality Management Systems.
- Good oral and written communication and presentation skills (Dutch and English).
- Ability to communicate with multiple departments and stakeholders.
- Getting things done and a hands-on mentality.
- A competitive remuneration package, including a yearly bonus, non-contributory pension and partial compensation on your personal health insurance.
- A stimulating environment with the opportunity to be part of an enthusiastic team that together is building the production site in Breda from the ground up.
- Attention for personal development.
- The possibility to contribute to the EU production site of our OPUS® column products.
Company profileRepligen is a bioprocessing-focused life sciences company bringing over 35 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, principally monoclonal antibodies.
Our manufacturing facilities are located at our Waltham, Massachusetts headquarters in the USA, and in Lund, Sweden, Weingarten, Germany , Rancho Dominguez, CA and Shrewsbury, MA. We market our products globally through a direct commercial organization in the U.S., Europe and Asia, as well as through strategic partners in select markets.
Please send your application to: Hannah Wensink