QA/QC - Quality Control Specialist - Senior

Applicants must be authorized to work in the United States on a full-time basis without the need for current or future visa sponsorship.

About the role

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, working to resolve these issues and improve quality globally.

Responsibilities

• Maintain manufacturer/supplier data in Agile and ensure all data associated with supplier assessments is kept current based on available information provided.
• Analyze supplier data and trends and proactively identify supplier issues.
• Participate 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.
• Remain knowledgeable about regulatory changes that could affect supplier and compliance quality.
• Ensure all audit-related documentation is communicated 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.
• Ensure corrective action-related documentation is reviewed and responded to within targeted timelines.
• Manage supplier corrective action plans to closure.
• Represent the company on assigned audits and projects.
• Serve as a corporate supplier quality resource for Client globally.
• Collaborate with supplier quality management team members to support regional needs for local manufacturing, local sourcing, and/or training while maintaining compliance with Client policies.
• Provide internal and external audit support as necessary, including conducting internal system audits of Client manufacturing and distribution centers as well as international subsidiaries.
• Support audits of Client by external agencies (FDA, TDH, CFDA, etc.).

Requirements

• 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 a GMP environment (Pharma, OTC, personal care, or dietary supplements).
• 3+ years of 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.
• Certified as a Preventive Controls Quality Individual (PCQI) is a plus.

Skills

• 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.
• Strong project and time management skills to ensure assigned activities are prioritized and completed within 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.
• Proficient in Microsoft Word, Excel (data management and analysis), Outlook, and Teams.

Benefits

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