- Conducts record review of executed batch records, QC testing data, and associated batch file documentation to ensure timely disposition of patient lots.
- Performs line/room clearance to support manufacturing activities in aseptic suites
- Print and issuance production labels, QC labels and final product labels
- Review and release raw materials and consumables for GMP use
- 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
- Demonstrated knowledge of document control systems, preferably electronic systems
- Ability to work on assigned projects independently with limited supervision
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Sr. Quality Assurance Specialist, Lot Disposition - Philadelphia, United States - Adaptimmune
Description
The Sr. Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release and facilitating timely release of production lots. The successful candidate will work closely with other Quality groups, Quality Control and Manufacturing to identify strategies, tactics and objectives for product quality and GMP compliance.
Key Responsibilities
Qualifications & Experience
Desirable
