American Gene Technologies is a leader in cell and gene therapy of infectious diseases, monogenic diseases, and cancer. Located in Rockville, Maryland, we are expanding the capacity for Research and Development of novel therapies and are seeking a Quality Assurance Specialist II for our Quality Assurance Team. This group supports AGT’s regulatory and clinical activities. The successful candidate must be skilled and experienced in the practice of quality assurance for Phase I/II Clinical trials for cell and gene therapy products.
- Reads, understands, and follows SOPs and aligns with cGMPs
- Writes new standard operating procedures or revises existing documentation utilizing document management systems
- Supports the evaluation and disposition of finished products through timely evaluation of batch records, laboratory results and other cGMP documents
- Electronic system usage with tools such as MasterControl, QT9 and ShareVault
- Reviews documented information and reports abnormalities.
- Assists in the implementation of new processes.
- Provides training to Specialists
- Conducts company trainings
- Initiates and/or reviews and approves deviations; completes tasks related to CAPA and Change Control.
- Proposes and implements new processes and other efficiencies as approved by management.
Skill, Knowledge and Abilities Required:
- Bachelor’s degree in Biology, Biotechnology, Chemistry, or science-related field preferred.
- At least 5 years’ experience with a Bachelor’s degree or 3 years’ experience with a Master’s degree
- GMP Phase 1 Gene and cell therapy experience is preferred
- Experience with internal auditing and supplier audits
- The flexibility to recognize changes in priorities and adjust as needed
- The ability to look for opportunities arising out of changing parameters
- Demonstrated ability to identify and implement cross-functional process improvements
- Excellent communication and interpersonal skills
- Demonstrated ability to take initiative and be a pro-active team member
- Working knowledge of other Quality Systems (ISO 17025, 9001, etc)
- ASQ Certified Quality Auditor preferred
Working Conditions and/or Physical Requirements
This is an office role that requires some physical mobility and physical effort. Biohazard precautions are required for working near gene therapy vectors, animal or human blood and tissue, or human pathogens.
The position reports directly to the Quality Assurance Manager.
American Gene Technologies (AGT) is an equal opportunity employer and will consider applications without discriminating based on disability, sex or sexual orientation, race or ethnic origin, marital or civil partnership status, or any other characteristic protected by law. AGT employees receive competitive salaries, comprehensive healthcare coverage, paid gym membership, 401K plan with employer contribution, incentive stock options, and annual paid leave.