Specialist, Quality Assurance - Operations - United States
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
Responsibilities (include but are not limited to):
- Work with the Manufacturing department as a production area Quality Assurance representative
- Coordinate and facilitate Quality Assurance related production and production related activities
- Ensure timely issuance of production records, procedures and labels
- Ensure timely assessment and closure of discrepancies, Deviations and Change Controls
- Review batch-related documentation, and ensure resolution of issues to release product
- Communicate lot disposition pending issues to Management
- Ensure approval and timely delivery of Final Product
- Ensure that products are manufactured in compliance with regulatory and GMP guidelines
- Review and approve Manufacturing and Validation documents for Regulatory and our company compliance
- Review and approve Manufacturing Production Records
- Compile and verify all batch related documents into a Final Product lot disposition package
- Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
- Review and disposition disposable raw materials and components for GMP use
- Review equipment and facility technical and investigation reports
- Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
- Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
- Perform other duties as required
- Bachelor’s degree in Biological Science or related field
- Minimum of 5 years Quality and/or Manufacturing experience in a pharmaceutical, biotech, or biologics operation.
- Working knowledge of Quality Systems and ability to apply GMPs in conformance to U.S. and EU standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Strong interpersonal, verbal and written communication skills
- Experience with manufacturing investigations, Deviations, and CAPA
- Experience with Change Control practices and strategies
- General knowledge of aseptic manufacturing processes
- Knowledge of equipment, facility, and utility IQ/OQ/PQ
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities