Quality Assurance Customer Service
Resume:
LETI DELGADO
**********@*****.***
OVERVIEW Green Belt Lean Six Sigma certified with thirteen years'
experience in the pharmaceutical industry.
Five years experience as a supervisor in Quality
Assurance.
TECHNICAL
SUMMARY ERP:Knowledge of Oracle JD. Edwards OneWorld ERP System.
MS Office: Advanced skills in Word, Excel, Access, and
Power Point
QA: Trackwise, Documentum
PROFESSIONAL
EXPERIENCE Clinic Manager Assistant
11/2009 -3/2010
Laser Salud y Vida 221 Romero Hidalgo, Lima, Per
Responsible for managing a staff of 4 technicians and a
receptionist.
Developed and Implemented an Operations Manual which
included policies, procedures, and protocols to maintain
the clinic high standards.
Planned, and scheduled the clinic work flow.
Acquired and implemented the software to track the
appointments, flow of medical records and patient
information.
Trained personnel on standardized procedures and good
customer service skills.
Acted as a liaison between patients, physician and laser
technicians in order to provide an outstanding patient
care.
Quality Assurance Supervisor
12/2004 -10/2009
Noven Pharmaceuticals 11960 SW 144th St Miami, FL 33186
Responsible for managing, leading, and motivating QA
staff of up to 10 inspectors.
Performed routine and year-end performance reviews on
direct reports. E-time
Trained and supervised new and current employees in the
quality departments regarding cGMP and other quality
related issues.
Maintained training documentation/ Training Matrix.
Review the batch record for compliance with regulations.
Participated in inspections, auditing and maintained
effective customer quality interactions.
Monitored manufacturing and QA areas to ensure compliance
with cGMP, product documentation, specifications, SOPs,
DEA, and FDA requirements.
Generated Change Control for the development and revision
of batch records, SOP's, forms, and controlled
documents..
Developed and distributed Monthly Department Metrics
Reports to upper management.
Investigated and prepared reports for process deviations,
failures, and corrective/preventive actions and followed
up on action to prevent the occurrence of
non-conformities related to our products, processes and
our quality system (CAPA). Generated final disposition
of non-conformance products.
Senior Quality Assurance Inspector
01/2002 -
Noven Pharmaceuticals Miami, FL
12/2004
Assisted management in monthly/quarterly metrics and
quality indicators, QA Alerts, QAI related activities,
sampling failures, deviations, and troubleshooting of
quality systems. Performed inspection and release of
manufacturing and packaging rooms and equipment.
Performed Sampling of In-process and finished products
using ASQ Z.14 AQL tables.
Inspected in process and final product to assure
conformance with the Batch Record. Organized Batch report
review in conformance with company SOP and GDP.
Generated Quality Alerts (hold) for discrepant/non
conformance products.
Reviewed and oversaw application of disposition labeling
on raw materials and components and maintained QA
inspection databases.
Quality Assurance Inspector - Operator
05/1995 -
Noven Pharmaceuticals Miami, FL
12/2001
Performed incoming, in-process, and finish product
sampling and Inspection.
Performed room and equipment releases including releasing
of components and raw material
Performed swabs, product holds, and pre-shipment sample
distribution for partners.
Performed room/equipment cleaning as per standard
procedures.
Operated packaging machine, performed machine set up
Performed production accountability for packaging.
Operator, Packer
03/1995 -
Nailtiques,12415 SW 136th Ave, Miami, FL 33186 -
06/1994
Packing products.
Prepare sample/Chinese boxes.
Using filling and capping machines.
Various other responsibilities
EDUCATION
Bachelor of Science with Major in Business Management
08/2003-
Jones College Miami, FL
08/2007
CERTIFICATIONS ASQ certifications:
& TRAINING Certified Quality Technician (CQT)
Certified Mechanical Inspector (CMI)
Certified Quality Improvement Associate (CQIA).
Certified Lean Six Sigma Green Belt
Successful completion of "cGMP for Pharmaceutical
Production Supervisors", by the Center for Professional
Advancement.
Attended Globepharm Seminar for "GMPs for Packaging
Personnel", "GMPs for QA personnel", and "Good
Documentation Practices", "Preparing for an FDA
Inspection" and "Fundamentals and Essentials of
Validation."
Successfully completed Air Academy Associates "Tools for
Continuous Process Improvement"
Participated in training from Guerra Consulting Group "A
GMP Approach to Detection, Correction, and Prevention of
Human Errors"
Certificate of Training on "How to Conduct an
Investigation" (Root Cause Analysis, corrective Action,
Proper Documentation and Problem solving)
Certificate of completion on "Equipment Change Control"
AWARDS &
MEMBERSHIPS Senior Member of American Society for Quality (ASQ)
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