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RESUME
BLANCA PADRINO,
MSQA, ASQ-CQA, CQMOE
Tobacco Pharma Supplements
OVERVIEW
I'm a certified auditor with a solid background in GMP, GDP, GLP, supplier chain, and manufacturing processes that ensures company operations adhere to the laws regulating the industry.
SKILLS
LANGUAGES
Goal oriented
Multitasker
Team Player
Leadership
English
Spanish
WORK EXPERIENCE
+ Compliant Specialist U.S., Latin American and Caribbean Region
ITG Brands
2017 - present
Conducting risk audits to ITGB facilities that require being compliant with the anticipated TPMP regulations. Providing orientation and support to facilities on FDA Regulations applicable to the tobacco industry. Supporting FDA internal, Supplier, and 3rd Party manufacturing facilities assessment. Developing QMS based on FDA regulations and GMP principles.
+ Compliance Specialist Quality Control
Noven Pharmaceuticals, Inc.
2014 - 2017
Conducted GMP/GLP Compliance to CFR-21 part 11/210/211 audits. Managed Corrective and Preventive Action and Effectiveness Check. Participated in Mock inspections and Audits. Lead Change control through Master Control and TrackWise for Standard Operational Procedures (SOP), Standard Test Procedures (STP), Specifications (Spec), and general documents. Lead process improvement projects. Stability studies and protocols
+ Quality Control Data Reviewer
Noven Pharmaceuticals, Inc.
2007 - 2014
As Reviewer; approved on LIMS laboratory results for HPLC/GC and physical testing for raw materials, intermediates, finished products and stability samples and data trend. Evaluated and approved LIMS product specifications, LIMS/ELN test scripts, QC Stability data migration and formula verification for QC testing. Reviewed process validation and stability protocols. Expertise in managing CR/CRT through Master Control and TrackWise for SOPs, STPs, Customer
Complaints, NOEs, and OOS/OOT investigations. As Noven certified auditor; conducted and supported internal audits for Product Life Cycle, Control Substances, and Laboratories. As Quality Professional; executed Lean Six Sigma Projects with outsourced consultants (Ventura Consultant Group). Lead and executed QC improvement projects for Raw Material Testing, Stability Data Entry, laboratory instruments utilization, capacity model, and Lean Paperless. As QC Reviewers group leader; created and monitored performance metrics and key indicators for efficiency, utilization and Lab improvement. Trained new laboratory personnel on STPs and SOPs for certification and qualification. Created, reviewed and improved training modules for QC Analysts. Performed routine control testing of stability Transdermal Delivery Systems for Potency, Release Rate, and Physical Testing.
EDUCATION
Master Degree in Science of Quality Assurance
California State University Dominguez Hills 1999-2014
Bachelor Degree In Sciences of Chemistry (Organic)
The University of Havana 1980-1985