Customer Quality Lead
Core
Plans, directs, and coordinates Quality Operational activities for dedicated customers to ensure team goals are accomplished within time frames and budget.
Role type
Customer Quality Lead (QA Operations)
Builds
Quality batch documentation and compliance for biopharma customers
Domain
Biopharmaceutical manufacturing / Quality Assurance
Required skills
cGMP compliance, batch documentation review, deviation investigation, data analysis, procedural development, training and mentoring, supplier investigation, metric reporting
Preferred skills
None stated
Technologies
Microsoft Office Suite
Responsibilities
Review completed and in-process orders for cGMP compliance; Act as company liaison for quality batch documentation; Identify and resolve document-related issues; Generate and present quality metrics and KPIs; Investigate quality deviations and draft reports; Disposition events and NONCs; Address quality events with Production and Quality teams; Train and mentor QA Technicians; Conduct in-process and finished goods inspections; Compile and analyze customer/internal data to identify trends; Assess impact of process changes on management.
Seniority
Individual Contributor, entry-level to mid-level
