Quality Assurance Specialist

Job Title: Quality Assurance Specialist Location: Indianapolis, IN Duration: Long Term Job Summary We are seeking a detail-oriented Quality Assurance Specialist to support quality agreement management activities within a GMP-regulated pharmaceutical/biotech environment. The ideal candidate will be responsible for drafting, reviewing, negotiating, and maintaining quality agreements to ensure compliance with GxP regulations and internal quality standards. The Quality Assurance Specialist will collaborate with internal cross-functional teams and external partners to support supplier qualification, regulatory compliance, and manufacturing readiness activities. 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 Coordinate 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 escalation 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 Ensure 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 Experience 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 #J-18808-Ljbffr Stark Pharma