Quality Control Specialist

Title: Quality Control SpecialistLocation: Lewisville, TX (on site)Duration: 6 month contract to hireCompensation: $35-41/hourWork Requirements: US Citizen, GC Holders or Authorized to Work in the U.S. Position OverviewThis 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 QualificationsEducationBachelor’s degree in a scientific or technical discipline such as Science, Technology, Engineering, Mathematics, or a closely related field.ExperienceMinimum 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 experienceCertificationsOne 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 ResponsibilitiesMaintain and update supplier/manufacturer data within internal systems, ensuring accuracy and completeness of assessment-related informationAnalyze supplier performance metrics and trends to proactively identify risks or issuesParticipate in cross-functional continuous improvement initiatives to enhance supplier quality and performanceDevelop audit plans and conduct assessments of new and existing global suppliers (including ingredients and component providers) to verify compliance with regulatory and quality standardsEnsure timely communication and documentation of audit findingsReview, track, and manage supplier corrective action plans through to completionAct as a quality representative on supplier audits, projects, and new product development teamsServe as a subject matter resource for supplier quality across global operationsCollaborate with regional teams to support local manufacturing, sourcing, and training while ensuring adherence to internal quality policiesSupport internal audits of manufacturing and distribution sites, as well as international operationsAssist with external regulatory inspections and audits conducted by agencies such as the FDA and other governing bodiesPerform duties on-site as requiredAdditional Skills & CompetenciesStrong understanding of: GMPs, GLPs, and applicable regulatory frameworksICH guidelines (Q7, Q9, Q10)21 CFR Part 11 and Parts 111, 210, and 211Quality systems, audit methodologies, inspection processes, and data integrity principlesFamiliarity with quality requirements in industries such as personal care, OTC products, and dietary supplementsAbility to manage multiple projects and prioritize tasks effectively to meet deadlinesExperience with continuous improvement tools and methodologiesStrong analytical thinking and problem-solving skillsAbility to work independently with minimal supervision and general directionProven effectiveness in a matrixed, global environment spanning multiple regions and culturesExcellent written and verbal communication skills, with the ability to clearly convey risks and issues to diverse stakeholdersProficiency in Microsoft Office tools, including: WordExcel (data analysis and management)OutlookTeamsInformation collected and processed through your application with INSPYR Solutions (including any job applications you choose to submit) is subject to INSPYR Solutions’ Privacy Policy and INSPYR Solutions’ AI and Automated Employment Decision Tool Policy: https://www.inspyrsolutions.com/policies/. By submitting an application, you are consenting to being contacted by INSPYR Solutions through phone, email, or text.