Dexian · 14 hours ago
Quality Assurance Specialist
Lewisville, TX
Full-time
Onsite
Mid Level
$35/hr - $42/hr
3+ years expDexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees worldwide. The Quality Assurance Specialist will serve as a technical expert for compliance quality issues, conduct internal audits, and support the Quality Systems team in ensuring adherence to global quality standards.
ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency
Hiring Manager
Abhishek Shitole
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 , Inc. by 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 ensures that the site is operating in 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, Inc. policies. Regularly assesses processes to determine if requirements are being met
Qualification
Required
3+ years of experience in quality assurance or quality control
Bachelor/University Degree in Chemistry or Microbiology
Good understanding of advanced quality principles, audit protocol, inspection procedures, and FDA and cGMP regulations
Familiarity with compliance requirements for over the counter (OTC) products
Ability to apply advanced principles, theories, and concepts
Critical thinker and active listener with good time management skills
Sound and comprehensive oral and written communication skills
Ability to perform duties under very general direction and independently perform assignments
Preferred
Knowledge and understanding of multiple manufacturing processes/formulations
Familiarity with international requirements
Bilingual skills
Company
Dexian
Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.
1001-5000 employees
H1B Sponsorship
Dexian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (65)
Funding
Current Stage
Late StageLeadership Team
Mahfuz Ahmed
Chairman of the Board
Vikram Motiani
Managing Director
Recent News
2025-11-19
Company data provided by crunchbase