Senior Quality Assurance Specialist
The Senior Quality Assurance Specialist 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 & 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.
Knowledge & 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.
Education, Work Experience and/or Licensure
- Bachelor’s degree in a science-related field, required; MS or Ph.D. preferred.
At least 10 years of experience in the pharmaceutical/medical device/diagnostic industry including at least 5 years or progressive management experience in QA and at least 5 years in a quality role are required.