Jason Hogeboom
Pacifica,CA
Summary
Experienced manufacturing and quality systems professional with expertise in process engineering, tech transfer, and regulatory compliance within GMP environments. Skilled in document control, risk management, and process optimization using Lean Six Sigma methodologies. Proven ability to lead teams, enhance operational efficiency, and ensure audit readiness in highly regulated industries.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Document Control Specialist (contract)
Corcpet
08.2024 - Current
- Organized and categorized over 1000 legacy records, ensuring audit readiness and smooth transition to Veeva QualityDocs system
- Reduced document retrieval time by creating a comprehensive index system that prioritized ease of use.
- Enhanced data accuracy by performing regular audits on documentation and records.
- Expedited information sharing between departments with the creation of an accessible central database for critical documents.
Product Specialist GMP CleanSuites
SmartLabs
10.2023 - 03.2024
- Acted as the GMP Technical/Regulatory Subject Matter Expert for nationwide sales team at SmartLabs
- Networked with potential clients at conferences, seminars, and trade shows, leading laboratory tours for clients
- Supported sales representatives during client meetings by providing expert knowledge on specific features or functionalities of the given product line
- Successfully navigated company termination of West Coast operations in 3/2024
Process Engineer (Contract)
Grifols
03.2023 - 08.2023
- Took over a large capital project from the lead engineer who was going on medical leave by revising, routing, and closing change controls via SAP, ensuring efficient document management
- Collaborated with quality, production, and engineering teams to develop and enhance processes for new and existing products
- Supported Materials Science and Technology (MS&T) specialists with technical expertise and problem-solving skills
- Provided technical assistance to production team when issues arose.
MSAT Manager
Vaxart
01.2021 - 03.2023
- Led team through first internal GMP process to create oral vaccine pills for COVID stage II clinical trials
- Provided oversight for Contract Manufacturing Organization (CMO) and reviewed batch records to ensure compliance with cGMP
- Offered technical manufacturing support for internal and external CMOs at Vaxart Inc
Doc Control / Lean Consultant (Contract)
Ultragenyx
10.2018 - 01.2020
- Authored and updated documents in Veeva EDMS to ensure FDA and ICH compliance
- Audited quality standards to improve operational efficiency and regulatory adherence
- Developed customized Lean training materials to facilitate knowledge transfer among team members
- Conducted value stream mapping exercises, identifying areas for improvement and optimization
Manufacturing Supervisor
Audentes
04.2016 - 03.2018
- Managed daily activities for the Cell Culture Production Department, overseeing associates, reviewing documents, and leading investigations
- Designed master control batch record templates and SOPs to move manufacturing of clinical materials into a GMP state
- Qualified all equipment for manufacturing
- Conducted root cause analysis on production issues, identifying solutions that prevented future recurrence of similar problems.
Manufacturing Supervisor
Baxter
02.2009 - 04.2016
- Managed daily activities for the Cell Culture Production Department, overseeing associates, reviewing documents, and leading investigations
- Created and updated SOPs, bath records, and forms, launching a Total Productive Maintenance Program (TPM) for efficiency
- Led continuous improvement projects to enhance inspection processes, reduce errors, and improve equipment uptime
- Completed production plans by scheduling and assigning personnel to daily tasks.
Education
MBA - Buisiness Administration
California State University, San Bernardino
San Bernardino, CA06.2017
Bachelor of Science - Business Administration, Communication Minor
California State University, Dominguez Hills
Carson, CA06.2015
AS - Natural Science
Skyline College
San Bruno, CA06.2011
Skills
- Manufacturing
- Quality Systems
- Quality Assurance
- Lean Black Belt
- Process Engineering
- FDA
- ICH
- EU Standards
- Situational Leadership
- Process Scale Up
- CAPA
- Risk Management
- Tech Transfer
- Technical Writing
- Project Management
- Operations
- QMS
- Document Control
Certification
- Lean Six Sigma Black Belt
Timeline
Document Control Specialist (contract)
Corcpet
08.2024 - Current
Product Specialist GMP CleanSuites
SmartLabs
10.2023 - 03.2024
Process Engineer (Contract)
Grifols
03.2023 - 08.2023
MSAT Manager
Vaxart
01.2021 - 03.2023
Doc Control / Lean Consultant (Contract)
Ultragenyx
10.2018 - 01.2020
Manufacturing Supervisor
Audentes
04.2016 - 03.2018
Manufacturing Supervisor
Baxter
02.2009 - 04.2016
MBA - Buisiness Administration
California State University, San Bernardino
Bachelor of Science - Business Administration, Communication Minor
California State University, Dominguez Hills
AS - Natural Science
Skyline College
Similar Profiles
Tom McDonaldTom McDonald
Investigator at City and County of San FranciscoInvestigator at City and County of San Francisco
KALLY WONG, BSN, RN, PHNKALLY WONG, BSN, RN, PHN
Home Health Registered Nurse at 21st Century Home Health AgencyHome Health Registered Nurse at 21st Century Home Health Agency
Sarah Pape-AlaimoSarah Pape-Alaimo
Office Manager at Scott Menary ConstructionOffice Manager at Scott Menary Construction
Juan CasarezJuan Casarez
Surgical Technologist at Campus Surgery CenterSurgical Technologist at Campus Surgery Center
Traci BoyerTraci Boyer
I-10 Corridor Contract 1 Project QA Records/Project Quality Records Manager/Document Control Manager at PQM, IncI-10 Corridor Contract 1 Project QA Records/Project Quality Records Manager/Document Control Manager at PQM, Inc