QA / QC - Quality Control Specialist - Senior

Job Number: 26-01114

Ready to take your career to the next level with a company that values innovation, leadership, and personal growth? ECLARO is looking for a QA / QC - Quality Control Specialist - Senior for our client in Lewisville, TX.

ECLARO’s client is an industry-leading organization that has built a reputation for excellence through its dedication to quality products, customer satisfaction, and employee development. Join a team where your contributions can help drive meaningful results on a global scale.

Position Overview:

• Contributes to the assurance that providers of outsourced products, materials, and services within the Global Supplier Quality Management system meet applicable Regulatory Authorities and global quality requirements.
• This is delivered by execution of documented assessments of cosmetic, over-the-counter, and nutritional / dietary supplement suppliers, management of supplier corrective actions to close identified gaps, maintenance of audit and supplier data in Business Systems, and support of quality agreement creations / renewals.
• Responsible for quality audit initiatives related to manufacturers and suppliers of materials, products or services used in development or manufacturing.
• Represents Corporate Quality on the new product development teams and serves as contact for supplier quality and quality compliance related issues and works to resolve these issues and improve quality global.

Responsibilities:

• Responsible for the maintenance of the manufacturer / supplier data in Agile and ensuring all data associated with supplier assessments is kept current based on available information provided.
• Analyzes supplier data and trends and proactively identifies supplier issues.
• Participates in continuous improvement projects across functional areas of the business to help improve supplier performance and ensure proper supplier quality management systems are maintained and consistently followed.
• Must remain knowledgeable about regulatory changes that could affect the supplier and compliance quality.
• Responsible for ensuring all audit related documentation is communicated out within targeted timelines to develop audit plans and execute audit assessments of new and existing global manufacturers and suppliers of ingredients and components to ensure quality and regulatory requirements are met.
• Responsible for ensuring corrective action related documentation is reviewed and responded to within targeted timelines.
• Manages supplier corrective action plans to closure.
• Represents the company on assigned audits and projects
• Serves as a corporate supplier quality resource for globally.
• Collaborates with supplier quality management team members to support regional needs for local manufacturing and / or local sourcing and / or training while maintaining compliance with Client's policies.
• Provides internal and external audit support as necessary. This support may include conducting internal system audits of manufacturing and distribution centers as well as international subsidiaries.
• Provides support for audits of by external agencies (FDA, TDH, CFDA, etc.).

Qualifications:

• Bachelor's degree in a Science, Technology, Engineering, Mathematical, or related science / technical discipline.
• 5+ years work experience (Quality, Engineering, or Manufacturing) in GMP environment (Pharma, OTC, personal care, or dietary supplements) and 3+ years audit experience.
• Certification by the American Society for Quality (ASQ) as a Certified Food Safety Quality Auditor (CFSQA), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Pharmaceutical GMP Professional (CPGP) or similar required. Certified as a Preventive Controls Quality Individual (PCQI) is a plus.
• Certified Quality Auditor.
• Knowledge of current GMPs, GLPs, ICH Q7, ICH Q10, ICH Q9, 21 CFR Part 11, and 21 CFR Parts 111, 210 and 211.
• Knowledge of quality principles, audit protocols, inspection procedures, data integrity principles, FDA regulations, and GMPs as applied to personal care, over-the-counter, and nutritional / dietary supplements industry.
• Possesses strong project and time management skills to ensure assigned activities are prioritized and completed with required timelines.
• Knowledge of continuous improvement tools / processes to participate in projects across functional areas of the business to resolve supplier issues.
• Critical thinker and active listener with ability to identify issues and provide solutions to a variety of problems.
• Ability to perform duties under very general direction and independently perform assignments with only general criteria for expected results.
• Demonstrated ability to function effectively in a matrix organization across multiple cultural and geographic boundaries.
• Excellent oral and written communication skills to interact with various levels of personnel from different cultures both within and outside the company to ensure effective rel…