Quality Assurance Analyst

Title: Quality Systems Analyst
Rate: $40-45/hour
Location: Lewisville, TX
Duration: 18+ month contract
Work Requirements: , or Authorized to Work in the US

Quality Systems Analyst
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.

Responsibilities:
25 % of Time

• Internal Auditor - Serves as member of the internal auditing program to ensure areas are operating in compliance with requirements. 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 standards and with other internal departments to ensure compliance with policies. Regularly assesses processes to determine if requirements are being met.

25% of Time

• 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 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.

20% of Time

• 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% of Time

• 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 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.

10% of Time

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

Skills & Experience:

• Experience: 3+ years
• Field of Experience: quality assurance or quality control
• Education: Bachelor/University Degree
• Education Focus: Chemistry, Microbiology

Preferred:

• 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

Our benefits package includes:

• Comprehensive medical benefits
• Competitive pay
• 401(k) retirement plan
• and much more!

About INSPYR Solutions:
Technology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.

INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.