Quality Systems Specialist

Location: Coppell, TX
Description: Our client is currently seeking a Quality Systems Specialist

Work Schedule:

• Days: 5 days in office (Monday to Friday)
• Hours: 8-4 or 9-6 (normal 8 hours/day)
• Interview: 1 round, in person

Top 5 Qualifications:

1. Investigations, root cause analysis, or corrective actions - Critical
2. Experience in computer system validation - Critical
3. Annual product review - Would be nice
4. Experience with validation, process, cleaning, or equipment validation - Would be nice
5. Any experience around any type of stability program - Would be nice

Preferred Certifications:

• Certified Quality Auditor
• Certified Quality Engineer
• Certified Quality Manager

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 the 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.

Responsibilities:

• Quality Management System (QMS): Responsible for duties relating to Quality Systems including but not limited to batch record review, document control, change control, annual OTC product review, validation support, stability support, review of quality events, and investigation of market quality events. Assist with approaches to continually improve and streamline processes to meet business and compliance requirements including development and incorporation of best practices. Supports additional special projects related to these objectives as required.
• Inspection Readiness: Must remain knowledgeable about significant global regulatory changes that could impact products. Assists with the implementation and monitoring of related systems, policies, and procedures. Supports efforts to ensure proper compliance quality management systems are maintained and that the global Quality standards are met and consistently followed. This support includes conducting internal system audits of manufacturing centers as well as International Subsidiaries. Provides support for audits of external agencies (FDA, TDH, Health Canada, etc.).
• Root Cause Analysis: Performs and advises on root cause analysis for product quality issues and works issue through containment phase of corrective action process. Supports investigation of internal and external failures to determine cause. Partners with various departments (including Quality, R&D, Manufacturing Operations, Purchasing, Package Engineering, and Legal) to request input to aid in feedback investigation, root cause identification, and implementation of actions to respond to both immediate issue resolution and long-term systemic resolution and prevention of recurrence. Follows up to verify that changes in the systems are implemented and monitors the systems over time to verify effectiveness.
• Internal Auditor: Serves as internal auditor ensuring that the site is operating in a state of compliance. This includes 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 management staff to support the needs of manufacturing while maintaining the quality standards and with other internal departments to ensure compliance with policies. Regularly assesses processes to determine if requirements are being met.

Skills & Experience:

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

Additional Skills & Abilities:

• Must have a good understanding of advanced quality principles, audit protocol, inspection procedures, and FDA and cGMP regulations. Must be familiar with compliance requirements for over-the-counter (OTC) products. 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.

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