Quality Assurance Associate Location: Hertfordshire Competitive Salary + Excellent Benefits
Do you have experience working in a GMP or Quality Assurance environment?
Would you like to work for a cutting-edge company working across modern Biological Therapeutics such as Gene Therapy and Cell Therapy?
My client, based in Stevenage, are specialists in the Research, Development and Commercialisation of Advanced therapy medicinal products, working with Biotechnology and Biopharmaceutical companies to translate early stage research into quality, commercially viable, scalable and investable therapies. They attract leading scientists from around the world, to join their R&D department, which boasts state of the art laboratories and facilities supporting Gene Therapy & Cell Therapy development and industrialisation.
My client is looking for a Quality Assurance Associate to support the QA team in the operation and maintenance of the Manufacturing Centre Quality Management System. This will include managing the issuing, storage, archive and access of a paper documentation system, generating system performance metrics and acting as "doc admin" in the electronic Quality Management System. You will provide entry level QA support in the review and approval of procedures and minor quality records as well as issuing controlled GMP documents to the rest of the Manufacturing Centre team.
- To perform the role of "doc admin" and "training coordinator" in the MasterControl eQMS
- To issue, review and reconcile controlled documents to both company and Collaborators, and to maintain satellite files
- To issue and maintain training files
- To maintain QMS trackers and to generate trends and graphs to support the system owner and for Management Review
- Support QMS system owners by engaging with teams to complete records on time
- Support with Collaborator and external regulatory inspection preparation, and participate in the inspection backroom
- To perform facility walkarounds assessing for compliance with established procedures
- To review basic quality documentation including, but not limited to, QC laboratory data, minor non-conformances and procedure updates
- Experience working in a GMP or Quality Assurance environment
- Experience in the use and operation of an electronic Quality Management System is an advantage
- Science degree is advantageous but not essential
Key Words " quality assurance, QA officer, QMS, quality management system, electronic quality management system, CAPA, deviations"
This is an excellent opportunity for someone to forge a career in Quality Assurance, within a renowned business in Hertfordshire.
Please apply online or call Umul Ahmed on 0203 0964529.
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