Quality Assurance Specialist - Supplier Quality

• Supports high-impact QA and supplier qualification activities
• Pharmaceutical Manufacturing
• Hybrid in Indianapolis, IN - 2 weeks/month onsite
• 12 month contract

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related scientific/technical field
• 3-5+ years of experience in a regulated pharmaceutical, biotech, or life sciences environment
• Direct experience managing quality agreements or similar GxP-controlled documentation
• Experience working cross-functionally with QA, Procurement, Legal, and Regulatory teams
• Proven ability to manage multiple concurrent deliverables in a fast-paced environment

Key Responsibilities

• Draft, review, and revise quality agreements in alignment with internal SOPs and GxP regulations
• Manage the full lifecycle of quality agreements, from initiation through negotiation, execution, and closure
• Partner with internal stakeholders (QA, Procurement, Legal, Regulatory) to resolve open items and obtain approvals
• Engage with external partners to negotiate terms, respond to redlines, and drive agreements to completion
• Maintain accurate tracking of agreement status, milestones, and version history within tracking systems
• Identify and escalate risks or delays that may impact supplier qualification, regulatory compliance, or manufacturing readiness
• Support continuous improvement initiatives related to quality agreement processes and templates

Regulatory Knowledge

• 21 CFR Parts 210/211
• ICH Q7 and Q10
• EU GMP (Chapter 7 / Annex 16)

Technical Skills

• Experience with Quality Management Systems (e.g., Veeva Vault, QDocs, or similar)
• Familiarity with procurement/contract systems (e.g., SAP, Ariba) preferred
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and collaboration tools
• Experience with tracking tools (e.g., Smartsheet or equivalent) strongly preferred

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.