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 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
• 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