Quality Assurance Coordinator

4basebio is an innovative gene synthesis company with the ambition to provide high quality, synthetic DNA for use in gene therapy and gene editing platforms. The company is growing rapidly and is establishing a GMP gene synthesis hub at its site just north of Cambridge, UK to facilitate the scaling and optimisation of our proprietary DNA manufacturing process. As QA Coordinator you will support the QA Team to build an effective Quality Management System (QMS), and to achieve and maintain compliance with current Good Manufacturing Practices (cGMP). The role is varied, requiring interaction with most of the QMS and teams across the business. As a result, flexibility, diligence and networking skills are essential.

Job Responsibilities:

  • Support key Quality elements such as deviations, document management, change control, Corrective and Preventative Actions (CAPAs), support training and training record management
  • Support audits by customers and regulatory bodies as needed
  • Support internal audits (self-inspections)
  • Monitoring of maintenance and calibration schedules and reviewing completed records where needed
  • Maintain QMS documentation, keep accurate records, follow instructions and comply with company policies in accordance with cGMP regulations
  • Advocate the importance of Quality and compliance and foster healthy collaborations with the Production and Quality Control Teams

Person Specification:

  • Educated to degree level and/or relevant experience
  • Experience working in Quality Assurance would be advantageous
  • Demonstrable understanding of relevant Quality Management Systems
  • Scrupulous attention to detail
  • Comfortable working autonomously or collaboratively
  • Methodical, organised and able to prioritise work effectively

What we offer:

Competitive salary + comprehensive benefits package

 

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