Responsibilities:
Quality Systems Administration
Maintain and administer the company Quality Management System (QMS)
Maintain the Quality Manual and associated controlled documents, procedures, forms, and records
Coordinate annual document review and revision schedules
Manage document control activities including revisions, archival, distribution, and official copies
Support Management Review preparation, metrics, and reporting
Maintain organizational charts and controlled quality documentation
Supplier & Customer Compliance
Maintain the Approved Supplier List (ASL)
Coordinate supplier qualification documentation and periodic supplier desk audits
Manage supplier quality agreements, NDAs/CDAs, and compliance documentation
Process supplier change notifications and coordinate customer communications
Complete customer desk audits, quality questionnaires, and compliance requests within required timelines
Support customer and supplier quality-related inquiries and documentation requests
Coordinate and maintain customer quality agreements as required
Corrective Actions & Complaint Management
Track and maintain customer complaints, Supplier Corrective Action Requests (SCARs), and Corrective and Preventive Actions (CAPAs)
Coordinate corrective action follow-up activities and supporting documentation
Maintain quality logs, investigation files, and summary reports
Support internal and external audit response activities
Coordinate customer responses related to complaint investigations and corrective actions
Training & Compliance Documentation
Maintain employee training records and training matrices
Coordinate annual training assignments and document reviews
Maintain employee compliance documentation and signature logs
Ensure training records remain current, complete, and audit-ready
Sustainability & ESG Programs
Coordinate annual sustainability reporting activities including EcoVadis, CDP, IntegrityNext, WorldFavor, and customer sustainability platforms
Support company sustainability initiatives and environmental compliance programs
Assist with carbon footprint reduction and waste reduction initiatives
Support collection and organization of sustainability and Scope 3 reporting data
Assist in evaluating future sustainability certifications and environmental initiatives
Qualifications:
Associate’s or Bachelor’s degree preferred; equivalent experience in regulated quality, compliance, or documentation environments will also be considered
3–7 years of experience in quality systems, compliance coordination, document control, supplier quality, or regulated business environments
Experience supporting regulated distribution, life science, biotech, pharmaceutical, medical device, laboratory supply, or related industries preferred
Experience working within ISO-based quality systems preferred
Strong organizational, administrative, and document management skills
Ability to manage multiple recurring deadlines and compliance activities
Strong written communication and follow-through capabilities
Proficiency with Microsoft Office, SharePoint, and document management systems