Supplier Quality Associate

Role Summary

The Supplier Quality Associate is a critical role responsible for overseeing the development and maintenance of a robust supplier quality program, managing external audit programs, and ensuring GMP compliance. This position drives supplier qualifications, conducts risk-based audits, and collaborates with cross-functional teams to maintain high-quality standards and support continuous improvement. The ideal candidate is detail-oriented with extensive experience in supplier quality management and GMP/GLP environments, capable of working independently to meet project goals while ensuring regulatory compliance.

• Develop and Maintain Supplier Quality Program:
  Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain
• Travel:
  Occasional travel may be required for supplier audits or vendor meetings
• Create Supplier Scorecards:
  Develop and maintain scorecards to evaluate supplier performance and drive accountability
• Ensure Audit Readiness:
  Maintain audit readiness and compliance with GMP and other regulatory standards
• Conduct Supplier Qualifications and Audits:
  Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality
• Manage SCAR
  
  Activities:
  
  Oversee all supplier corrective action processes, ensuring timely resolution of issues
• Collaborate on Material Specifications:
  Work with cross-departmental teams to develop and refine material specifications
• Prepare Quality Metrics:
  Compile and present quality metrics to stakeholders to support decision-making
• Address Quality Issues:
  Partner with internal teams to resolve supplier quality and audit-related challenges
• Drive Best Practices:
  Contribute to the development and implementation of best practices to enhance compliance and performance
• Perform Data Analysis:
  Conduct data analysis and maintain organized records, reports, and databases to support quality processes
• Implement Continuous Improvement:
  Recommend and implement measures to enhance quality processes and operational efficiency
• Present Data Internally:
  Deliver data-driven insights to support decision-making and quality initiatives
• Work Independently:
  Operate with minimal supervision to achieve project goals and meet deadlines
• Review and Approve Documents:
  Review and approve assigned documents to ensure accuracy and compliance
• Perform Additional Duties:
  Undertake other quality-related responsibilities as assigned to support organizational objectives

• Education:
  
  Bachelor’s degree in a relevant Biological Science discipline required
• Experience:
  
  3 years of experience in a GMP Quality Control laboratory or GMP/GLP setting required, with direct experience in Supplier Quality Management and corporate/supplier audits
• Experience conducting audits is a plus
• Supplier/Vendor
  
  Qualification:
  
  3+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring
• SCAR Management:
  Experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues
• SOP Development:
  Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance
• Experience facilitating Supplier Quality Agreements is a plus
• Technical
  
  Skills:
  
  Proficiency in Outlook, MS Office, and eQMS is a plus
• Communication and Teamwork:
  Excellent communication, time-management, and teamwork skills to collaborate effectively across departments
• Organizational
  
  Skills:
  
  Strong organizational skills and attention to detail to manage records, reports, and databases
• Multitasking:
  Ability to prioritize and manage multiple responsibilities in a fast-paced environment
• Work Environment Adaptability:
  Ability to gown and work in classified areas for audits or inspections
• Independent Work:
  Ability to independently perform tasks, generate reports, and escalate issues as needed
• ASQ CQA certification preferred; candidates without current certification must demonstrate a willingness and ability to obtain certification within a specified timeframe
• Strong team player with the ability to collaborate effectively across cross-functional departments

• Bachelor’s degree in a relevant Biological Science discipline

• Travel:
  Occasional travel may be required for supplier audits or vendor meetings
• Work Environment and Physical Demands:
  Setting primarily office- and laboratory-based; gowning in classified areas; prolonged computer use; occasional lifting up to 20 pounds