QA Associate, GMP - United Kingdom - Achilles Therapeutics Limited

Description

Achilles is a fast paced, trail blazing company. We are breaking new ground with our science creating products that have never been made. As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organisation, working together to solve novel problems. This entrepreneurial spirit and approach runs through our company and those who thrive here are able to cope with anything that is thrown at them, enjoy ambiguity and thrive on making things happen even when there is not a detailed brief.

The role is based in Stevenage which is a key facility in manufacturing of the company's personalised T cell therapy products for use across Achilles clinical trial programmes.

This role will play a key part in supporting and maintaining the quality systems and processes to maintain operations for GMP production and Quality Control testing.

Additionally, ensuring GxP and other regulatory requirements relating to clinical trial manufacture are met and maintained for ATIMPs (Advanced Therapy investigational Medicinal Product).

Responsibilities:

• Support operational QA duties to ensure GxP compliance and other regulatory requirements relating to the manufacturing and conduct of clinical trials
• Support the administration of the document management system
• QA review and approval of procedures, master batch records, and any other relevant cGMP documentation
• Perform batch documentation review activities
• Review standard operating procedures (SOPs) to ensure compliance with GMP and other relevant regulatory requirements
• Support, review and approval of change controls, non-conformances and CAPAs
• Providing manufacturing and quality control functions with QA support
• Review and approve out of specification investigations
• Work with teams across the business and externally to investigate quality issues
• Support complaints management process and where appropriate respond to complaint investigations
• Support with any qualification & validation activities
• Perform internal audits to determine compliance with GMP and identify areas for improvement
• Support the hosting customer audits and regulatory inspections
• Support of provision of In-house training activities
• Provide support and data for Achilles quality management reviews

Experience

• Demonstratable work experience in a QA role with a Biotech/Biologics/ATMP GMP Environment, ideally on MIA /MIA IMP Licensed Site.
• Baseline technical knowledge of aseptic manufacturing processes, sterility assurance and laboratory techniques
• Knowledge about regulatory requirements for ATIMPs
• Baseline understanding of UK, EU and US GMP requirements
• We will consider individuals with a QC background who have experience of QA activities and can demonstrate competencies to pick up technical knowledge quickly.

This is a permanent role, offering a competitive benefits package

At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership, and teamwork. We work hard and deliver a lot

Our benefits package includes a competitive salary and performance related bonus, group pension plan matched up to 6%, life insurance, private medical insurance, and a tax approved all employee share incentive plan.