Title: Quality Control Specialist
Location: Lewisville, TX (on site)
Duration: 6 month contract to hire
Compensation: $35-41/hour
Work Requirements: US Citizen, GC Holders or Authorized to Work in the U.S.
 
Position Overview

• This role supports supplier quality assurance activities for outsourced products, materials, and services. The position ensures that all suppliers comply with applicable regulatory standards and established quality requirements. Responsibilities include conducting supplier audits, managing corrective actions, maintaining supplier data systems, and supporting quality agreements.
• The role also participates in new product development initiatives, represents quality functions in cross-functional teams, and serves as a key contact for supplier quality and compliance matters. The objective is to resolve quality issues, strengthen supplier performance, and enhance global quality standards.

Minimum Qualifications

• Education
  Bachelor’s degree in a scientific or technical discipline such as Science, Technology, Engineering, Mathematics, or a closely related field.
• Experience
• Minimum of 5 years of experience in Quality, Engineering, or Manufacturing within a GMP-regulated environment (e.g., pharmaceuticals, OTC products, personal care, or dietary supplements)
• At least 3 years of auditing experience

Certifications

• One or more of the following certifications (or equivalent) is required:

• Certified Quality Auditor (CQA)
• Certified Quality Engineer (CQE)
• Certified Food Safety Quality Auditor (CFSQA)
• Certified Pharmaceutical GMP Professional (CPGP)

Preferred:

• Preventive Controls Qualified Individual (PCQI)

Key Responsibilities

• Maintain and update supplier/manufacturer data within internal systems, ensuring accuracy and completeness of assessment-related information
• Analyze supplier performance metrics and trends to proactively identify risks or issues
• Participate in cross-functional continuous improvement initiatives to enhance supplier quality and performance
• Develop audit plans and conduct assessments of new and existing global suppliers (including ingredients and component providers) to verify compliance with regulatory and quality standards
• Ensure timely communication and documentation of audit findings
• Review, track, and manage supplier corrective action plans through to completion
• Act as a quality representative on supplier audits, projects, and new product development teams
• Serve as a subject matter resource for supplier quality across global operations
• Collaborate with regional teams to support local manufacturing, sourcing, and training while ensuring adherence to internal quality policies
• Support internal audits of manufacturing and distribution sites, as well as international operations
• Assist with external regulatory inspections and audits conducted by agencies such as the FDA and other governing bodies
• Perform duties on-site as required

Additional Skills & Competencies
Strong understanding of:

• GMPs, GLPs, and applicable regulatory frameworks
• ICH guidelines (Q7, Q9, Q10)
• 21 CFR Part 11 and Parts 111, 210, and 211
• Quality systems, audit methodologies, inspection processes, and data integrity principles
• Familiarity with quality requirements in industries such as personal care, OTC products, and dietary supplements
• Ability to manage multiple projects and prioritize tasks effectively to meet deadlines
• Experience with continuous improvement tools and methodologies
• Strong analytical thinking and problem-solving skills
• Ability to work independently with minimal supervision and general direction
• Proven effectiveness in a matrixed, global environment spanning multiple regions and cultures
• Excellent written and verbal communication skills, with the ability to clearly convey risks and issues to diverse stakeholders

Proficiency in Microsoft Office tools, including:

• Word
• Excel (data analysis and management)
• Outlook
• Teams

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