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% Requirements 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 preferredExperience 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. Core Competencies 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. #J-18808-Ljbffr