Supplier Quality Specialist

Responsibilities

• Maintain Cosette Supplier Management Program under the direction of Supplier Quality Management
• Drive and maintain the Cosette Supplier Management Program to include supplier records and supplier CAPA Audits and reporting
• Risk assessments
• Create and update quality agreements
• Perform/support supplier audits
• Collaborate with cross functional teams to onboard new suppliers and maintain current suppliers
• Maintain metrics for adherence to the supplier audit schedule
• Participate in internal, customer, and regulatory audits as needed
• Support projects as requested
• Travel up to 25%

• Bachelor’s Degree in a scientific/technical discipline; advanced degree preferred
• 3+ years of experience in the pharmaceutical/regulated products industry, with a focus on Quality Control and Quality Assurance
• Support of Regulatory Agency (FDA, EMA) Inspection Experience preferred
• Technical Writing
• Analytical Methods
• Root Cause Techniques
• CAPA System
• GMP Training
• Quality Management Review
• Validation Practices
• Data Integrity
• Quality Management Systems
• Analytical Chemistry
• External Vendor Auditing Experience preferred
  
  Experience with MS Word, Excel, and Project
• Experience with eQMS required
• Experience with document control/management in a regulated environment
• Fundamental knowledge of quality systems in regulated environments
• Customer focused, initiative, interdependent partnering
• Good organizational and planning skills
• Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation
• In-depth understanding of good documentation practices in a GMP environment
• Ability to make and guide quality/compliance decisions that are data based and commensurate with risk.

Demonstrates expertise in Supplier Management Programs, Quality Control, and Quality Assurance within the pharmaceutical industry, with a strong focus on regulatory compliance and quality systems. Proficient in technical writing, risk assessments, and maintaining adherence to quality standards in a GMP environment.