Job Summary
Serves as technical/subject matter expert for compliance quality related issues and works to resolve these issues and improve quality globally. Serves as internal auditor and member of Quality Systems team. Assists in the day-to-day operations of Quality Systems processes including but not limited to Batch Record Review, Over the Counter (OTC) Drug and Nutritional Product Release, Annual Product Review (APR), Validation Support, Change Control, Training, Document Control, Document Distribution, Investigation and Root Cause Analysis, and Inspection Readiness.
Skills & Experience
Experience: 3+ years
Field of Experience: quality assurance or quality control
Education: Bachelor/University Degree
Education Focus: Chemistry, Microbiologoy
Decision Making: 4-Uses judgment based on the analysis of information
Additional Skills & Abilities
- 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.
- Ability to apply advanced principles, theories, and concepts and contribute to the development of new principles, systems and concepts.
- 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.
- 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.
- Must be able to perform duties under very general direction and independently perform assignments with only general criteria for expected results.