Erik Zepeda
Perris,CA
Summary
Results-driven Pharmaceutical Manufacturing Lead with 19 years of experience in GMP-compliant environment’s. Skilled in overseeing manufacturing operations, ensuring regulatory compliance, and leading cross-functional teams to optimize efficiency and quality. Passionate about continuous improvement, and maintaining the highest safety and quality standards.
Overview
19
19
years of professional experience
Work History
Manufacturing Lead
Catalent Pharma Solutions
07.2018 - 11.2024
- Responsible for manufacturing GMP products, following SOPs, and providing accurate documentation in production batch records
- Leading manufacturing technicians during GMP operations
- Operating and troubleshooting automated and semi-automated equipment
- Drafting production comments and variances as needed
- Establishing workflow in production suites and identifying process efficiencies to promote GMP compliance
- Equipment set up, calibration, and troubleshooting
- In-process checks and final product check
- Segregating QC samples for Retain, Release, and Stability, along with AQL and MET sampling
- Microbalances, Analytical balances, Top Loading balances, Bench scales, 300kg balances, and Moisture analyzers
Process Operator II
Actavis/Teva
08.2005 - 01.2017
- Executing Manufacturing and R&D productions while performing batch record step and following all applicable SOPs, providing accurate calculations and documentation.
- Training new onboarding operators with entry level equipment and procedures.
- Monthly and quarterly cycle counts, providing accurate amounts for all API and excipient materials updating JDE.
- Contributed to a safe working environment by strictly adhering to safety guidelines and reporting potential hazards.
- Maintained accurate records of production data, facilitating informed decision-making for management.
Education
Universal Technician - HVAC-R
UEI College
Ontario, CA04-2018
High School Diploma -
Perris Lake High School
01.2004
Skills
- SOP’s Development & Adherence
- CGMP Compliance
- R&D Process Validation & Qualification
- Batch Record & Logbook Review and Documentation
- Deviation, CAPA, and Change Control Management
- Production Scheduling and Workflow Optimization
- Forklift Certified
- JDE Knowledge
- Employee training and development
- Cross-functional team leadership
- Strong work ethic
Timeline
Manufacturing Lead
Catalent Pharma Solutions
07.2018 - 11.2024
Process Operator II
Actavis/Teva
08.2005 - 01.2017
High School Diploma -
Perris Lake High School
Universal Technician - HVAC-R
UEI College
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