Jacob Baca
Thornton,CO
Summary
Results-driven training and quality specialist with expertise in GMP regulations and lean manufacturing. Committed to enhancing operational efficiency through effective training delivery and data-driven quality assessments.
Overview
9
9
years of professional experience
Work History
Specialist - Training and Quality
AGC Biologics
Longmont, Colorado
01.2022 - 11.2025
- Designed and delivered GMP training curricula for 300+ staff across two startup CO sites, achieving 99% compliance with FDA and global regulations (EU & ICH).
- Conducted data analysis, and ensured documentation control for startup Colorado locations.
- Designed and delivered department specific training programs for new employees in biopharmaceutical processes.
- Executed quality assurance assessments to verify compliance with regulatory standards.
- Collaborated with cross-functional teams to develop training materials and manuals for department Boot Camps.
- Facilitated workshops to develop employee skills in critical operational areas (CAPA, Audit, Change Control),
- Evaluated training effectiveness through participant feedback and performance metrics.
- Mentored junior staff in training best practices and quality standards.
- Point Quality System Contact for Learning Management system (SalesForce TrackWise).
- Designed and delivered Train the Trainer programs.
- Conducted quality audits to ensure compliance with industry standards.
BioProcess Associate
Novartis Pharmaceuticals
Longmont, Colorado
11.2019 - 11.2021
- Achieved 100% batch completion for purification production following CGMP protocols.
- Executed manual operations, including chemical weighing and equipment assembly/disassembly, to ensure compliance with production protocols.
- Acted as primary trainer for new hires in media and buffer operations techniques.
- Reviewed documents and revised SOPs to align with regulatory standards and maintain operational integrity.
- Manipulated hazardous materials safely during operations to prevent incidents.
- Employed 5S methodologies for continuous improvement in work areas.
- Coordinated cross-departmental data verification efforts to improve data accuracy and support decision-making.
- Contributed to establishment of gene therapy division by supporting multi-site manufacturing efforts.
Manufacturing Technician
KBI Biopharma
Boulder, Colorado
01.2019 - 11.2019
- Streamlined operations by implementing lean manufacturing principles.
- Managed procurement of equipment, installations, and transfers, resulting in improved operational efficiency.
- Implemented specific guidance during production from engineering personnel during production runs.
- Developed new processes for improved efficiency in production.
- Compiled and analyzed statistical data, ensuring product quality and reliability standards were met.
- Evaluated industrial operations for compliance with regulations and permits, contributing to safer work practices.
Manufacturing Technician
Agilent Technologies Inc. Nucleic Acids Division
, CO
05.2017 - 01.2019
- Performed quality control checks ensuring product compliance with FDA & Eudralex (EU) standards.
- Conducted quality checks on finished products to ensure accuracy.
- Diagnosed and resolved equipment malfunctions to ensure smooth operations. to minimize operational downtime.
- Operated laboratory equipment for nucleic acid production processes.
- Performed machine set-up activities prior to start up of production run.
- Instructed new technicians in laboratory safety and operational procedures.
- Assisted in training other technicians on proper use of equipment and safety protocols.
- Adhered to applicable regulations, policies and procedures for safety and environmental compliance.
Education
Associate of Science - EMT-Health
Front Range Community College
Westminster, CO05-2016
Skills
- GMP curriculum development
- Instructor-led training
- Training delivery
- Training evaluation
- Quality assurance
- Compliance verification
- Quality management
- ISO standards
- Data analysis
- Lean manufacturing
- Equipment calibration
- Process troubleshooting
Timeline
Specialist - Training and Quality
AGC Biologics
01.2022 - 11.2025
BioProcess Associate
Novartis Pharmaceuticals
11.2019 - 11.2021
Manufacturing Technician
KBI Biopharma
01.2019 - 11.2019
Manufacturing Technician
Agilent Technologies Inc. Nucleic Acids Division
05.2017 - 01.2019
Associate of Science - EMT-Health
Front Range Community College