Anthony Saitta

In addition to responsibilities perform prior to becoming a Lead:

• Manage and develop a team of direct reports with a wide range of experience levels and varying educational and work experience backgrounds.
• Manage multiple projects simultaneously while adhering to strict deadlines and quality standards.
• Collaborate with teams to gather requirements and clarify optimized approaches to Change Controls, CAPAs, and Qualification projects.
• Perform risk assessments pertaining to data integrity and applying ALCOA++ principles and adhering to regulatory guidance including FDA and Annex 11 cGMP Regulations.
• Collaborate with teams to gather requirements and clarify optimizes approaches to Change Controls, CAPAs, and Qualification projects.
• Collaborate with cross-functional teams to identify opportunities for process improvement and increased efficiency.
• Optimize operational efficiency by redesigning workflow processes.

• Executed onboarding of analytical and supplementary equipment, ensuring successful purchase, installation, and qualification across multiple Quality Control labs.
• Contributed to cross-functional projects and quality investigations, facilitating corrective actions and preventive actions (CAPA) to enhance compliance.
• Drafted and executed testing protocols for equipment qualifications, ensuring adherence to regulatory standards and operational efficiency.

• Performed analysis of pharmaceutical finished products using various methods including iCIEF, CE-SDS, and Western Blot.
• Documented results in LIMS, maintaining accurate traceable records for review and reporting.
• Troubleshot analytical instruments, resolving calibration and performance issues to sustain workflow continuity.
• Reviewed raw data and calculations, ensuring method accuracy and data integrity across testing batches.