- 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
Job Description
Job DescriptionAdaptimmune 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.
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
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.
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