Responsibilities:
Quality Systems Administration
Maintain and administer the company Quality Management System (QMS)Maintain the Quality Manual and associated controlled documents, procedures, forms, and recordsCoordinate annual document review and revision schedulesManage document control activities including revisions, archival, distribution, and official copiesSupport Management Review preparation, metrics, and reportingMaintain organizational charts and controlled quality documentation
Supplier & Customer Compliance
Maintain the Approved Supplier List (ASL)Coordinate supplier qualification documentation and periodic supplier desk auditsManage supplier quality agreements, NDAs/CDAs, and compliance documentationProcess supplier change notifications and coordinate customer communicationsComplete customer desk audits, quality questionnaires, and compliance requests within required timelinesSupport customer and supplier quality-related inquiries and documentation requestsCoordinate 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 documentationMaintain quality logs, investigation files, and summary reportsSupport internal and external audit response activitiesCoordinate customer responses related to complaint investigations and corrective actions
Training & Compliance Documentation
Maintain employee training records and training matricesCoordinate annual training assignments and document reviewsMaintain employee compliance documentation and signature logsEnsure training records remain current, complete, and audit-ready
Sustainability & ESG Programs
Coordinate annual sustainability reporting activities including EcoVadis, CDP, IntegrityNext, WorldFavor, and customer sustainability platformsSupport company sustainability initiatives and environmental compliance programsAssist with carbon footprint reduction and waste reduction initiativesSupport collection and organization of sustainability and Scope 3 reporting dataAssist 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 considered3-7 years of experience in quality systems, compliance coordination, document control, supplier quality, or regulated business environmentsExperience supporting regulated distribution, life science, biotech, pharmaceutical, medical device, laboratory supply, or related industries preferredExperience working within ISO-based quality systems preferredStrong organizational, administrative, and document management skillsAbility to manage multiple recurring deadlines and compliance activitiesStrong written communication and follow-through capabilitiesProficiency with Microsoft Office, SharePoint, and document management systems
| Location | Frederick, MD |