Senior Quality Assurance Specialist

3 weeks ago

Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time

**Job Summary**

The Autolus Limited team is seeking a highly skilled Senior Quality Assurance Specialist to join our Product Delivery Quality Assurance team. As a key member of our team, you will play a critical role in ensuring the delivery of autologous CAR T-cell products in compliance with Good Manufacturing Practice (GMP).

Key Responsibilities:

  • Maintain the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies.
  • Control of record forms for use in production and QC, applying batch or test article identity traceability features and maintaining an audit trail of issue, use and reconciliation and archiving.
  • Preparation, checking and issue of in-process and Drug Product labels, ensuring compliance with the authorised template and the batch-specific/patient-specific data thus maintaining product traceability and regulatory compliance.
  • Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues.
  • Authoring, approval and review of GxP documentation.
  • Supplier management: Assessment and qualification (or disqualification) of raw material suppliers, including audits; Audits of GMP contractors conducting outsourced activities; and Risk Job assessments.
  • Materials review and release for use in Production and QC, ensuring that only approved suppliers and materials are available.
  • Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, microbiological out-of-trend and out-of-specification results and other environmental excursions.
  • Continuous improvement.
  • Process and equipment qualification and validation.
  • Analytical and Quality Control assay validation.
  • First point of escalation issues and communication to QPs.
  • Collation and trending of Quality KPIs.
  • Support Product Quality Review.
  • Conducting internal audits as lead auditor in accordance with a defined schedule in a supporting capacity.
  • Support regulatory inspections - backroom support and/or SME support.
  • Line management of Junior Quality Assurance colleagues.

Requirements:

  • 2-5 years' experience (ideally industrial) in equivalent roles, with responsibility for quality assurance in a pharmaceutical or equivalent quality management system.
  • Experience with MHRA (E) and HTA (P) inspections, either as host or involved contract giver to a manufacturing site.

Qualifications:

  • BSc in pharmaceutical sciences, immunology or equivalent experience (E).
  • MSc in pharmaceutical sciences, immunology or equivalent experience (P).

Skills/Specialist knowledge:

  • GMP & GCP principles.
  • Manufacturing and testing procedures for advanced therapies.
  • The basis of CAR T-cell technology.
  • Good communication skills and ability to motivate colleagues.
  • Ability to build strong collaborative cross-departmental relationships.
  • Skills to work within a team, understanding his/her responsibilities and delegating to others and remain accountable for his/her work.
  • The ability to work independently to a high standard with minimal direction from a manager.

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