QA/QC - Quality Control Specialist - Senior

ECLARO; Lewisville (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

401k Retirement Savings Plan

Commuter Benefits

Medical, Dental & Vision Insurance

Job summary

ECLARO is seeking a Senior QA/QC - Quality Control Specialist to lead supplier quality initiatives in Lewisville, TX. The role focuses on GMP compliance, audits, and continuous improvement across global suppliers and materials.

The ideal candidate will have 5+ years in GMP environments, 3+ years audit experience, and ASQ certifications. Proficiency in Word, Excel, Outlook, and Teams is required for data management and collaboration.

Qualifications

• Bachelor/University Degree in a Science, Technology, Engineering, Mathematical, or related discipline.
• 5+ years in GMP environments (Pharma, OTC, personal care, or dietary supplements) with 3+ years audit experience.
• ASQ certifications such as CFSQA, CQA, CQE, CPGP or similar; PCQI is a plus.
• Strong project and time management abilities and process improvement experience.
• Excellent written and verbal communication; capable of working in a matrix organization.

Responsibilities

• Maintain supplier data in Agile and ensure updates align with supplier assessments.
• Analyze supplier data and trends to proactively identify issues.
• Support continuous improvement projects to enhance supplier quality management systems.
• Stay current on regulatory changes affecting suppliers and compliance.
• Ensure audit documentation is communicated on time and audit plans are executed.
• Manage supplier corrective action plans to closure and document responses.
• Represent the company on audits and supplier quality initiatives globally.
• Collaborate with supplier quality teams to address regional needs and training.
• Provide internal/external audit support, including system audits and regulatory inspections.

Skills

Quality Assurance

Auditing

Regulatory Compliance

GMP Knowledge

Data Analysis

Project Management

Cross-functional teamwork

Education

Bachelor's in Science/Engineering

ASQ Certifications

Tools

Microsoft Word

Microsoft Excel

Outlook

Teams

Job description

QA / QC - Quality Control Specialist - Senior

Job Number: 26-01462

Ready to take your career to the next level with a company that values innovation, leadership, and personal growth? ECLARO is looking for a QA / QC - Quality Control Specialist - Senior for our client in Lewisville, TX.

ECLARO’s client is an industry-leading organization that has built a reputation for excellence through its dedication to quality products, customer satisfaction, and employee development. Join a team where your contributions can help drive meaningful results on a global scale.

Position Overview:

• Applicants must be authorized to work in the United States on a full-time basis without the need for current or future visa sponsorship.
• Contributes to the assurance that providers of outsourced products, materials, and services within the Client Global Supplier Quality Management system meet applicable Regulatory Authorities and Client global 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 Client 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 Client globally.
• 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 Client policies.
• Provides internal and external audit support as necessary. This support may include conducting internal system audits of Client manufacturing and distribution centers as well as international subsidiaries.
• Provides support for audits of Client by external agencies (FDA, TDH, CFDA, etc.).

Qualifications:

• Knowledge of current GMPs, GLPs, ICH Q7, ICH Q10, ICH Q9, 21 CFR Part 11, and 21 CFR Parts 111, 210 and 211.
• 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.
• Bachelor / University Degree Education Focus: Bachelor's degree in a Science, Technology, Engineering, Mathematical, or related science / technical discipline.
• 5+ years of work experience (SQM, Quality, Engineering, or Manufacturing) in GMP environment (Pharma, OTC, personal care, or dietary supplements) and 3+ years audit experience.
• 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

If hired, you will enjoy the following ECLARO Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

Equal Opportunity Employer

ECLARO values diversity and does not discriminate based based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.