Quality Assurance Specialist
Core
Lead routine walkthroughs, conduct internal audits, and maintain accurate quality records to support safe, consistent medications in a 503A/503B compounding and manufacturing environment.
Role type
Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
Compounded medications and pharmaceutical products
Domain
Healthcare / Pharmaceutical Manufacturing / Quality Assurance
Required skills
cGMP compliance, FDA/USP standards knowledge, root cause analysis, quality risk assessment, process improvement, deviation investigation, internal auditing, documentation management
Preferred skills
Certified Quality Auditor (CQA), Certified Quality Improvement Associate (CQIA)
Technologies
Microsoft Office
Responsibilities
Lead routine walkthroughs of compounding and manufacturing areas, conduct internal audits of site operations, support cross-functional deviation investigations, implement corrective and preventive actions, maintain complete and accurate quality records, prepare inspection readiness documentation
Seniority
Mid-level, hands-on IC
