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Specialist Quality Management

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Research & Development
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JOB PURPOSE:    
Serves as an internal auditor and a member of the Quality Systems team. Serves as technical/subject matter specialist for compliance related issues and works to resolve these issues and improve quality. Assists in the day-to-day operations of Quality Systems processes, such as Document Control Management, Change Control Reviews, Quality Investigation and Root Cause Analysis, OTC batch record audits and Quality process training across the organization. Responsible for quality activities for the Finished Good Specifications, OTC Batch Record, OTC Finished Good Release, Annual Product Review, FDA Audit Readiness, Key Performance Indicators, and Quality Event Management. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:     
1. Internal Auditor - Serves as member of the internal auditing program to ensure areas are operating in compliance with requirements of Mary Kay, Inc. The process will include developing audit plans and performing audits while meeting timeline objectives as well as documenting/ reporting audit results including corrective action plans when applicable. Collaborates with quality management staff to support the needs of manufacturing while maintaining the Mary Kay quality standards and with other internal departments to ensure compliance with Mary Kay, Inc. policies. Regularly assesses processes to determine if requirements are being met.

2. Quality System Management - Responsible for duties relating to Quality Systems, including but not limited to batch record review, document review, change control, decision analysis and resolution, annual OTC product review, and calibration oversight to ensure that quality management systems are maintained, and standards are met and consistently followed. Develops training material and recommendations that promote awareness and understanding of Mary Kay Inc. quality requirements, standards, Policies, SOP, and Work Instruction procedures and processes. Assist with approaches to continually improve and streamline processes to meet business and compliance requirements including development and incorporation of best practices.   

3. Root Cause Analysis - Investigates internal failures to determine cause and advises on root cause analysis for product quality issues. Reviews investigations for completeness and provides feedback to various departments to assist in accurate identification of root cause and appropriate actions.  Contributes to site awareness on root cause analysis tools and technique trainings. Monitors and reports on quality performance metrics on predetermined frequency.  

4. CAPA - Follows up to verify that changes in the systems are implemented and monitors the CAPA system over time to verify effectiveness. Assists in the identification and implementation of processes, policies or procedures to continuously improve the product and compliance quality of Mary Kay Inc. Collaborates with various departments (including Quality, R&D, Operations, Procurement, Package Engineering, and Legal) regarding gaps in compliance or gaps in the consistent execution of quality standards to formulate recommendations for immediate action, and systemic resolution and prevention of recurrence.  

5. FDA Readiness - Assists with the management of audits by external agencies (FDA, TDH, Health Canada, etc.).

In addition to the above, incumbent is expected to meet the required competencies for this position as defined in the competency profile.

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. 

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