Senior Quality Assurance Specialist

6/28/2019

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.


Job Type : Full-Time
Education Level : Bachelors Degree, Masters, Doctoral
Experience Level : Mid to Senior Level
Job Function : ""
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