Quality Assurance Specialist Jobs

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

Quality Assurance and Quality Control are responsible for the timely testing, review, and release of life-saving medicine. The Quality team has a hand in all matters relating to manufacturing, routine batch testing, regulatory updates/requirements, process development, stability/raw material control, and much more. Being on the team at Adaptimmune allows an individual to fully immerse themselves into a clinical trial from the initiation via a new IND all the way through to a commercial manufacturing product.

Primary Responsibility

The Quality Assurance Specialist provides support and guidance for all products manufactured at Adaptimmune, LLC. Following Adaptimmune, LLC Quality Policies and Procedures, the Quality Assurance Specialist participates in the activities related to product release, Quality investigations, auditing, customer complaints, CAPA, raw material, in-process and final product release.

Key Responsibilities

• Generate controlled copies of the Master Batch Records, Logbooks, Forms, Validation Protocols and other GxP documents
• Liaison with functional business units to develop and continuously improve department training and qualification programs
• Support training compliance in site Learning Management System
• Assist in ensuring periodic reviews are completed in time
• Review and Approve Deviations, ensuring timely closure
• Review and approve CAPA Effectiveness Checks
• Approving Document Change Requests within the Document Management system
• Assist in driving CAPA closure to meet assigned due dates
• Ensure adequate investigations have been performed to drill down to root cause and risk assessed
• Assess Adaptimmune CMC training program and documents for compliance
• Perform notification to QPs on newly issued deviations associated with associated country T-cell lots

Qualifications & Experience

• Experience with Deviations, CAPA and Document Control
• Understanding of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP)
• Requires BS/BA in scientific discipline or related field with minimum 3 years of relevant work experience in biologics, cell and gene therapy or related industry

Desirable

• Knowledge of cell therapy production processes
• Knowledge of aseptic processing

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.