Location
Addison, TX | United States
Job description
currently seeking a Quality System Analyst for an 18 month contract opportunity that is located in Addison, TX. 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.
- 25% of time: Internal Auditor - Serves as member of the internal auditing program to ensure areas are operating in compliance with requirements of company. 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 company quality standards and with other internal departments to ensure compliance with company policies. Regularly assesses processes to determine if requirements are being met.
- 25%: 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 company 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.
- 25%: 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.
- 20%: 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 company. 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.
- 20%: FDA Readiness - Assists with the management of audits by external agencies (FDA, TDH, Health Canada, etc.).
- 10%: This job requires on-site work at a Mary Kay facility.
REQUIREMENTS
- Please include an example or sample of investigation situation, root cause analysis or corrective action taken.
- Investigations root cause analysis or corrective actions
- Experience computer system validation.
- 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.
PREFERRED (NOT REQUIRED)
- Annual product review
- Experience with validation, process, cleaning, or equipment validation.
- Any Certified Quality Auditor
- Certified Quality Engineer
- Certified Quality Manager experience around any type of stability program
Report this job
- Dice Id: 91087746
- Position Id: RCRM26207
Job tags
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