Quality Assurance Officers

Quality Control Specialist / Quality Assurance Specialist

Contract to hire role

Pay Rate - $41/hr on W2

Location - Lewisville, TX on site 5 days a week first 90 days then potentially Hybrid 1 to 2 days per week.

Qualifications

Education: Bachelor/University Degree in a Science, Technology, Engineering, Mathematical, or related science/technical discipline.

5+ years work experience in Quality, Engineering, or Manufacturing in a GMP environment (Pharma, OTC, personal care, or dietary supplements); 3+ years audit experience.

Certification by ASQ as a Certified Food Safety Quality Auditor (CFSQA), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Pharmaceutical GMP Professional (CPGP) or similar. PCQI is a plus.

Proficiency in Microsoft Word, Excel, Outlook, and Teams.

Knowledge of GMPs, GLPs, ICH Q7, Q10, Q9, 21 CFR Part 11, Parts 111, 210, and 211; and FDA regulations applicable to personal care, OTC, and dietary supplements.

Strong project and time‑management skills, with knowledge of continuous‑improvement tools and processes.

Excellent oral and written communication skills; ability to function effectively in a matrix organization across multiple cultures and geographic boundaries.

Job Summary

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 executing documented assessments of cosmetic, over‑the‑counter, and nutritional/dietary supplement suppliers, managing supplier corrective actions to close identified gaps, maintaining audit and supplier data in business systems, and supporting quality agreement creation/renewals. The specialist is 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 the contact for supplier quality and quality compliance issues, working to resolve these issues and improve quality globally.

Responsibilities

Maintain manufacturer/supplier data in Agile and ensure data associated with supplier assessments is kept current. Analyze supplier data and trends, proactively identify supplier issues, and participate in continuous‑improvement projects across functional areas to improve supplier performance and ensure consistent adherence to supplier quality management systems.

Develop audit plans and execute audit assessments of new and existing global manufacturers and suppliers of ingredients and components, ensuring quality and regulatory requirements are met. Communicate all audit‑related documentation within targeted timelines, review and respond to corrective‑action documentation, and manage supplier corrective‑action plans to closure. Represent the company on assigned audits and projects.

Serve as a corporate supplier quality resource globally, collaborating with supplier quality management team members to support regional needs for local manufacturing, local sourcing, or training while maintaining compliance with policies.

Provide internal and external audit support as necessary, including internal system audits of manufacturing and distribution centers and audits of international subsidiaries.

Support audits conducted by external agencies such as FDA, TDH, CFDA, and similar organizations.

Perform work on‑site at the facility.

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