Diana De Leon
Greenville
Summary
Detail-oriented pharmaceutical professional with 4+ years in sterile/aseptic manufacturing, documentation control, SAP batch tracking, and frontline leadership. Experienced training operators, coordinating daily operations, supporting deviation investigations, and ensuring compliance with cGMP, SOP, and data integrity standards. Strong collaborator with QA, Engineering, and Maintenance, with a proven ability to promote safety, continuous improvement, and team engagement. Lean Six Sigma Green/Black Belt. Bilingual in English and Spanish.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Sr Administrative Services Coordinator
Thermo Fisher Scientific
Greenville, NC
11.2025 - Current
- Conducted detailed review of manufacturing and Filling batch records to ensure compliance with Current Good Manufacturing Practice (cGMP) and internal Standard Operating Procedures (SOPs).
- Verified documentation accuracy and data integrity according to ALCOA+ Data Integrity Principles, ensuring proper entries, signatures, calculations, and timestamps.
- Identified and resolved documentation discrepancies, omissions, and deviations by collaborating with Production, Quality Assurance, and laboratory teams.
- Supported deviation investigations and corrective actions to maintain regulatory compliance and improve documentation processes.
- Maintained lifecycle management of batch documentation including issuance, review, reconciliation, and archival in accordance with GMP standards.
- Entered and tracked batch status and quality data using systems such as SAP, LIMS, and TrackWise.
- Analyzed batch record trends and documentation errors to support continuous improvement and strengthen GMP compliance.
- Ensured audit-ready documentation and supported regulatory inspections by the U.S. Food and Drug Administration and internal quality audits.
- Authored and revised SOPs, risk assessments, and audit-trail documentation.
Senior Formulation Technician
Thermo Fisher Scientific
11.2024 - 11.2025
- Lead and coordinate shift activities ensuring SOP, cGMP, and safety compliance.
- Mentor and train technicians; serve as SME for documentation and aseptic practices.
- Operate and troubleshoot aseptic filling equipment, autoclaves, washers, and isolators.
- Support deviation investigations and contribute to CAPA implementation.
- Communicate priorities between operators, leads, and supervisors to ensure smooth workflow.
- Review and execute batch records and logbooks with full data integrity compliance.
- Collaborated with cross-functional teams to refine product formulations based on customer feedback.
Line Coordinator
Pfizer
03.2024 - 11.2024
- Reviewed and closed batch manufacturing steps in SAP ensuring compliance and accuracy.
- Coordinated investigations for batch errors; supported RCA and CAPA development.
- Led cross-functional teams to enhance production efficiency and optimize workflows.
- Developed and implemented standard operating procedures for line operations, ensuring compliance with safety regulations.
- Trained new team members on equipment operation and quality control standards, fostering a collaborative work environment.
- Coordinated daily production schedules, aligning resources to meet demand while minimizing downtime and delays.
- Facilitated communication between departments to address operational challenges and streamline processes effectively.
Formulation Technician II
Thermo Fisher Scientific
10.2020 - 03.2024
- Performed aseptic formulation, sterilization, buffer prep, and cleanroom operations.
- Supported documentation review, validation activities, and GMP record compliance.
- Operated sterilizers, integrity testers, isolators, washers, and controlled-environment equipment.
- Trained new staff in sterile technique, gowning, and documentation accuracy.
- Trained operators on documentation accuracy and SOP adherence; served as SME for audits.
- Plan daily work assignments and oversee task execution to maintain schedule adherence.
- Delegate responsibilities, guide team performance, and ensure operational readiness.
- Track production metrics, identify inefficiencies, and support continuous improvement initiatives.
- Logged material usage and maintained GMP-compliant documentation.
- Collaborated with cross-functional teams to streamline production workflows.
- Developed and optimized formulation processes for diverse product lines.
Education
A.S. - Business Administration
Wake Tech
03-2026
High School Diploma - undefined
North Pitt High School
01-2020
Skills
- GMP Compliance & Documentation Control
- Team Leadership, Delegation & Training
- Aseptic Technique & Sterile Manufacturing
- Batch Record Review, SAP & Data Integrity
- SOP Authoring, RCA & CAPA Support
- Equipment Operations (Isolators, Washers, Autoclaves)
- Lean Six Sigma Green/Black Belt
- Microsoft Office (Excel, Word, PowerPoint)
- Bilingual: English & Spanish
Certification
- BioWorks Certification
- Sterile Manufacturing Certification
- Lean Six Sigma Green/Black Belt
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Sr Administrative Services Coordinator
Thermo Fisher Scientific
11.2025 - Current
Senior Formulation Technician
Thermo Fisher Scientific
11.2024 - 11.2025
Line Coordinator
Pfizer
03.2024 - 11.2024
Formulation Technician II
Thermo Fisher Scientific
10.2020 - 03.2024
High School Diploma - undefined
North Pitt High School
A.S. - Business Administration
Wake Tech