Specialist Quality Management

KNOWLEDGE, SKILLS AND ABILITIES    

Education:  Bachelor’s degree in chemistry, microbiology or related discipline;

Experience: 3+ years of experience or a Master’s degree with minimum of 1+ years of experience in quality assurance or quality control.  Certification by the American Society for Quality (ASQ) as an ASQ Certified Quality Engineer (CQE), Certified Manager of Quality/Organizational Excellence (CMQ/OE) or Certified Quality Auditor (CQA) is strongly preferred.

1. Must have a good understanding of advanced quality principles, of audit protocol, inspection procedures and FDA and cGMP regulations. Must be familiar with compliance requirements for over the counter (OTC) products.  A knowledge and understanding of multiple manufacturing processes/formulations, international requirements and bilingual skills are beneficial.

2. Ability to apply advanced principles, theories, and concepts and contribute to the development of new principles, systems and concepts.

3. Must be a critical thinker and active listener with good time management ability to provide solutions and define deliverables to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity.  Solutions should be imaginative, thorough, and practicable.

4. Must have sound and comprehensive oral and written communication skills to interact with various levels of personnel from different cultures both within and outside the company.

5. Must be able to perform duties under very general direction and independently perform assignments with only general criteria for expected results.