Jimbo Poblete
Spring Valley
Summary
Dynamic Quality Manager with extensive experience at CSL Plasma, adept in regulatory compliance and CAPA implementation. Proven track record in risk management and internal audits, ensuring adherence to FDA regulations. Skilled in root cause analysis and process improvement, complemented by strong organizational skills and a commitment to quality assurance.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality Manager
CSL Plasma
San Diego
01.2023 - Current
- Managed oversight of quality systems at a center level.
- Managed a small team of quality personnel
- Deviation management and CAPA implementation
- Led and ensured center compliance to FDA/GHA regulations and various regulatory agencies
- Conduct observations and MSQRs
- Led and assisted various centers for internal and external audits (FDA, GHA etc.)
- Risk mitigation and root cause analysis
- Implement SOP changes in the donor center
- QA review and release of softgoods and supplies for production use.
- QA release of plasma units for further manufacturing at PLC
- QA release of SPE and VMT samples
- Submission of periodic Proficiency testing/ QA review of CLIA personnel.
- QA review of equipment received/transferred and equipment incidents
- Applied lookbacks/destruction of plasma units
- Well-understanding of CGMPS and Good Documentation Practices
- Maintained/Updated Controlled Documents
- ASQ-CQIA certified
Quality Associate II
Pacira BioSciences, Inc.
San Diego
11.2022 - 12.2022
- QA quarantine and release of raw materials
- Perform sampling of various raw materials
Quality Specialist
CSL Plasma
San Diego
08.2020 - 11.2022
- Conduct observations and MSQRs
- Led and assisted various centers for internal and external audits (FDA, GHA etc.)
- Risk mitigation and root cause analysis
- Implement SOP changes in the donor center
- QA review and release of softgoods and supplies for production use.
- QA release of plasma units for further manufacturing at PLC
- QA release of SPE and VMT samples
- Submission of periodic Proficiency testing/ QA review of CLIA personnel.
- QA review of equipment received/transferred and equipment incidents
- Applied lookbacks/destruction of plasma units
- Well-understanding of CGMPS and Good Documentation Practices
- Maintained/Updated Controlled Documents
- ASQ-CQIA certified
Medical Screener/Processing Technician
Octapharma Plasma Inc
San Diego
08.2017 - 08.2020
- Opened and updated files with current donor information
- Maintained clean, neat and properly sterilized work area
- Obtained patient vitals such as heart rate, weight and blood pressure
- Utilized finger sticks and centrifuges to accurately check hematocrit levels and obtain plasma samples
- Processed plasma units and samples
- Prepared shipments of plasma samples for testing
- Maintained and repaired Genesys PCS machines
Education
Bachelor of Science - Food And Nutrition
San Diego State University
San Diego, CA08.2017
Associate of Science - Nutrition
Southwestern College
Chula Vista, CA01.2015
GED -
Chula Vista Adult School
Chula Vista, CA09.2011
Skills
- Organizational Skills
- Quality management
- Flexible and adaptable
- Internal audits
- Manufacturing
- FDA regulations
- Lean
- CGMP
- Data Entry
- Writing and documentation
- Troubleshooting
- Documentation review
- Microsoft Excel
- Customer service
- ISO 9001
- Quality systems
- Root cause analysis
- Proficient in Microsoft Office
- NexSys PCS Technician support
- Lean Six Sigma
- Six Sigma
- Quality assurance
- TrackWise
- Regulatory compliance
- CAPA implementation
- Risk management
- Process improvement
- Problem solving
- Attention to detail
Certification
- ASQ Certified Quality Improvement Associate (CQIA), Present
- Lean Six Sigma Yellow Belt, Present
- BLS Certification, Present
- First Aid Certification, Present
Languages
- Tagalog, Fluent
- English, Fluent
- Spanish, Intermediate
Affiliations
- Guitarist
- Music
Timeline
Quality Manager
CSL Plasma
01.2023 - Current
Quality Associate II
Pacira BioSciences, Inc.
11.2022 - 12.2022
Quality Specialist
CSL Plasma
08.2020 - 11.2022
Medical Screener/Processing Technician
Octapharma Plasma Inc
08.2017 - 08.2020
Bachelor of Science - Food And Nutrition
San Diego State University
Associate of Science - Nutrition
Southwestern College
GED -
Chula Vista Adult School
Similar Profiles
ANTON MCDOWELLANTON MCDOWELL
Donor Floor Support Trainer, •Reception Tech, •Rika Services Technician, •Safety Inspector at CSL Plasma, Plasma ProcessingDonor Floor Support Trainer, •Reception Tech, •Rika Services Technician, •Safety Inspector at CSL Plasma, Plasma Processing
Jide AdeshiyanJide Adeshiyan
Associate Operations Manager at CSL PlasmaAssociate Operations Manager at CSL Plasma
Reginald ClineReginald Cline
Support Technition at CSL PlasmaSupport Technition at CSL Plasma
Arabella HernandezArabella Hernandez
Reception/technician & Processor at CSL PlasmaReception/technician & Processor at CSL Plasma
Moshe GoldbergMoshe Goldberg
Owner at Greens Cap Funding LLCOwner at Greens Cap Funding LLC