Senior Quality Assurance Specialist
Sanaria Inc. is a Rockville, Maryland based biotechnology company that is dedicated to the production of an attenuated sporozoite malaria vaccine. We currently have an opening for a Senior Quality Assurance Specialist.
The position will be responsible for further developing and maintaining the quality system and developing quality assurance policies, programs and procedures for the company's clinical product, a novel malaria vaccine. This position will be responsible for defining processes or improving processes for receiving, manufacturing, packaging, testing and distribution for the clinical vaccine.
Essential Duties and Responsibilities:
Responsible of daily QA activities and related cGMP compliance.
Manage deviations, investigations, OOS and CAPA
Raw data review for GXP reporting
Change Control Management
Internal audits and external vendor Audit
Perform GXP training
Supplier Quality Management
Clinical Product release and COA generation
Work directly with the Senior Management to assure both continuous improvement of the Quality System and provide leadership for the overall Quality Management system.
Knowledge and Abilities:
In depth knowledge of US and EU GMP s
In depth knowledge of USP and EP compendium
In depth knowledge of aseptic and sterile product quality
Prior involvement in establishing quality systems and experience in biologics/vaccines are preferred.
Strong communication, project management, leadership skills and excellent written and oral English language skills are essential.
The ability to work in a fast paced environment with multiple and competing priorities is essential.