Quality Agreement Specialist
Core
Supports quality assurance operations by managing and negotiating Customer Quality Agreements, responding to technical inquiries, and maintaining quality documentation for pharmaceutical and laboratory products.
Role type
Quality Agreement Specialist
Builds
Customer Quality Agreements and quality documentation for pharmaceutical and laboratory product lines
Domain
Pharmaceutical and biopharmaceutical manufacturing
Deliverable
client delivery
Required skills
Knowledge of cGMP, FDA, ICH, and WHO regulations, Quality and process engineering, Microsoft Office Suite, Database management
Preferred skills
Laboratory or manufacturing environment experience, Project management, Lean principles
Technologies
Microsoft Office Suite, Databases
Responsibilities
Manage and negotiate Customer Quality Agreements with the legal team, Respond to customer technical and quality inquiries, Research technical documents and product specifications, Participate in designing/improving quality agreement processes, Participate in cross-functional customer intimacy programs
Seniority
Mid-level, hands-on IC