Quality Control Specialist

Lancesoft; Lewisville (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Lancesoft seeks a Supplier Quality Management professional to assure outsourced product quality and regulatory compliance across global suppliers. You will manage supplier data, drive audits, and oversee CAPA processes in alignment with GMP and FDA requirements.

The role requires on-site work, strong data management skills, and collaboration across multiple departments to maintain supplier quality excellence.

Qualifications

• Knowledge of current GMPs, GLPs, ICH Q7, ICH Q10, ICH Q9, 21 CFR Part 11, and 21 CFR Parts 111, 210 and 211.

Responsibilities

• Maintain manufacturer/supplier data in Agile and ensure data accuracy for supplier assessments.
• Conduct audits of global manufacturers and suppliers to ensure quality and regulatory compliance.
• Support supplier quality audits, CAPA review, escalation, and effectiveness verification.
• Serve as a corporate supplier quality resource and collaborate across functions to meet MKI policies.

Skills

GMPs knowledge

GLPs knowledge

ICH Q7 knowledge

ICH Q10/Q9 knowledge

FDA regulations familiarity

Project management

data analysis

communication skills

Tools

MS Word

Excel

Outlook

Teams

Job description

Contributes to the assurance that providers of outsourced products, materials, and services within the company’s Supplier Quality Management system meet applicable Regulatory Authorities and company’s 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 company’s 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 the company. 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 MKI policies.
• Provides internal and external audit support as necessary. This support may include conducting internal system audits of company manufacturing and distribution centers as well as international subsidiaries.
• Provides support for audits of the company by external agencies (FDA, TDH, CFDA, etc.).
• This job requires on-site work at the company facility.

Additional Skills & Abilities:

• Knowledge of current GMPs, GLPs, ICH Q7, ICH Q10, ICH Q9, 21 CFR Part 11, and 21 CFR Parts 111, 210 and 211. April 13, 2026
• 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 relay of issues and risks so they are understood and addressed.
• Must be proficient in Microsoft Word, Excel (data management and analysis), Outlook, and Teams to manage job duties.

***SQM Expectations:

• Supplier qualification and approval of supplier/manufacturer sites sites.
• Supplier audits, audit preparation, audit execution, audit reporting, and audit finding closure.
• Supplier corrective and preventive action management, including CAPA review, escalation, and effectiveness verification.
• Supplier quality events, quality incidents, deviations, nonconformances, complaints, or material issues involving external suppliers.
• Supplier performance monitoring through scorecards, KPIs, metrics, probation, escalation, or business reviews.
• Risk-based supplier oversight, including supplier classification, audit frequency, product/category risk, and manufacturer site risk.
• Cross-functional decision-making with Procurement, Regulatory, Product Integrity, Manufacturing, R&D, Quality Systems, and Operations.
• Ability to influence suppliers without direct authority and drive timely, evidence-based resolution.
• 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