Quality Assurance Specialist

Key Responsibilities

• Draft, review, revise, and maintain quality agreements in alignment with internal SOPs, GxP regulations, and company quality standards
• Manage the full lifecycle of quality agreements from initiation through negotiation, execution, renewal, and closure
• Partner with Quality Assurance, Procurement, Legal, Regulatory, and Manufacturing teams to resolve open items and obtain required approvals
• Cook up with external vendors, suppliers, and business partners to negotiate agreement terms and address redline comments
• Maintain accurate tracking of agreement status, milestones, approvals, and version history within document management systems
• Identify, communicate, and escalate risks or delays that may impact supplier qualification, product quality, regulatory compliance, or manufacturing operations
• Support deviation investigations, CAPA activities, and change control processes related to quality systems documentation
• Affirm compliance with FDA, cGMP, GDP, and internal quality management system requirements
• Assist with internal audits, supplier audits, and regulatory inspections by providing quality documentation and support
• Participate in continuous improvement initiatives related to quality agreement processes, templates, and document workflows

Requirements

• 3 - 5+ years of experience in a regulated pharmaceutical, biotechnology, medical device, or life sciences environment
• Direct experience managing quality agreements, supplier quality documentation, or GxP-controlled records
• Strong understanding of FDA regulations, cGMP, GDP, and quality systems requirements
• Experience with document management systems, change control, CAPA, and deviation management processes
• Strong technical writing, communication, negotiation, and organizational skills
• Ability to manage multiple projects and deadlines within a fast-paced regulated environment