Sara Spacek

I’m a Quality Assurance Supervisor with hands-on experience building and operationalizing cGMP quality systems in fast-paced, regulated environments. My foundation is rooted in QMS implementation, pharmaceutical QC operations, investigations, and inspection readiness, supported by a B.A. in Chemistry.

In my most recent role, I built the cGMP quality management system (QMS) operating model and advanced 180+ controlled documents from concept to active drafting and formal review within 120 days. I led cross-functional QMS implementation across Quality, QC Chemistry, QC Microbiology, IT, and Laboratory Operations, and established document lifecycle tracking with KPI dashboards to improve visibility, accountability, and execution cadence.

I also brought structured risk and control to daily operations by establishing validation master plans and ICH Q9–aligned risk frameworks. I integrated risk with deviations, corrective and preventive action (CAPA), and change control processes, while serving as a QA point of contact for acquisition planning, vendor coordination, and EQMS implementation for other sites within the parent organization.

Earlier as a Quality Analyst, I performed thousands of technical reviews for finished pharmaceutical products and raw materials, reviewed OOS investigations for sound root cause determination and product disposition, and strengthened compliance with pharmacopeial standards and FDA cGxP requirements. I supported ISO gap assessments and FDA inspection readiness through on-site response coordination and document retrieval, and I contributed to continuous improvement by revising SOPs and performing subvisible particulate testing for 503B outsourcing facilities.