Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies for ophthalmic diseases. The Quality Assurance (QA) Specialist provides quality oversight of internal and external activities, documentation and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals.
- The Quality Assurance Specialist will report directly to the Director of Quality Assurance.
Essential Duties and Responsibilities
Job responsibilities will include, but are not limited to, the following.
- Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs
- Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations
- Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
- Write, review and revise standard operating procedures
- Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
- Perform in-phase inspections in support of GLP studies, write inspection reports and prepare QA statements
- Perform internal and external audits of GxP vendors; assist in the resolution of non-conformances, deviations and investigations.
- Track open observations and Corrective and Preventative Actions (CAPA) to closure.
- Assist with the analysis of trends and metrics to ensure continuous quality improvements.
The successful candidate will meet the following requirements.
- B.S. degree in a scientific discipline and 3 to 5 years’ experience working in a GLP/GMP environment, preferably in a biotechnology company
- In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures
- Great attention to detail. Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines
- Strong interpersonal skills. Excellent verbal and written communication skills
AGTC offers a competitive compensation commensurate with education and experience, including salary, benefits, and company equity. AGTC is an EOE and maintains a drug-free workplace. Please send CV or resume to: email@example.com