Senior Quality Assurance Specialist for Lot Disposition
1 week ago
At Adaptimmune, we are committed to delivering high-quality cell therapy products to patients with cancer. As a Senior Quality Assurance Specialist for Lot Disposition, you will play a critical role in ensuring the quality and safety of our products.
Key Responsibilities:
- Conduct record reviews of batch records, QC testing data, and associated batch file documentation to ensure timely disposition of patient lots.
- Perform line/room clearance to support manufacturing activities in aseptic suites.
- Print and issue production labels, QC labels, and final product labels.
- Review and release raw materials and consumables for GMP use.
Qualifications & Experience:
- Bachelor's Degree in a scientific discipline.
- Minimum of 5 years in a global biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
- Direct experience with review and approval of batch records and QC testing data.
- Knowledge of aseptic processing and aseptic gowning techniques.
- Broad knowledge of GMP, ICH, and FDA/EMA regulations.
- Broad knowledge of Quality Systems, such as Change Control, Investigations, and CAPA.
- Ability to identify and implement continuous improvement projects as relating to Quality Assurance Operations and the Quality Management System.
- Demonstrate knowledge of an ability to apply cGMP and quality system regulations.
- Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities.
Desirable:
- Demonstrated knowledge of document control systems, preferably electronic systems.
- Ability to work on assigned projects independently with limited supervision.
Adaptimmune is an equal opportunities employer and welcomes applications from all qualified candidates.
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