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QA / QC - Quality Control Specialist - Senior

ECLARO

Lewisville, TX

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JOB DETAILS
SKILLS
Agile Programming Methodologies, American Society for Quality (ASQ), Auditing, Biotech and Pharmaceutical, Business Solutions, Certified Quality Engineer (CQE), Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Customer Satisfaction, Data Analysis, Data Management, Data Quality, Dental Insurance, Develop and Maintain Customers, Distribution Services, Diversity, Documentation, Establish Priorities, External Audit, FDA (Food and Drug Administration), FDA Requirements, Food Quality, Food Safety, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Genetics, ICH Regulations, Identify Issues, Information Technology/Systems Audit, Internal Audit, Leadership, Maintain Compliance, Manufacturing, Manufacturing Systems, Mathematics, Matrix Management, Microsoft Excel, Microsoft Outlook, Microsoft Word, Outsourcing, Performance Management, Personal Care, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Product Development, Quality Assurance, Quality Control, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Staff Development, Time Management, Trend Analysis, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Planning, Vendor/Supplier Quality Management, Vendor/Supplier Selection, Vision Plan, Writing Skills
LOCATION
Lewisville, TX
POSTED
Today
QA / QC - Quality Control Specialist - Senior
Job Number: 26-01114

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:
  • Contributes to the assurance that providers of outsourced products, materials, and services within the Global Supplier Quality Management system meet applicable Regulatory Authorities and 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 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 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's policies.
  • Provides internal and external audit support as necessary. This support may include conducting internal system audits of manufacturing and distribution centers as well as international subsidiaries.
  • Provides support for audits of by external agencies (FDA, TDH, CFDA, etc.).

Qualifications:
  • Bachelor's degree in a Science, Technology, Engineering, Mathematical, or related science / technical discipline.
  • 5+ years work experience (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.
  • 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.

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

If interested, you may contact:
Paul Joseph
Pjoseph@eclao.com

Equal Opportunity Employer: ECLARO values diversity and does not discriminate 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.

About the Company

E

ECLARO

Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:

• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities

Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:

• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services

Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.

Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
http://www.eclaroit.com