Engineer Quality

MARGARET HIRALDO

*** ******* ****** *******@*********.*** Home: 919-***-****

Clayton, North Carolina LinkedinURL:mhiraldo Mobile: 954-***-****

SUMMARY

A Quality Professional that has extensive years of experience within the Quality, Manufacturing, Research / Development and Technical Support arena with proven success in process improvement, Six Sigma, ISO 9000, Project Management, Reformulations, Problem Solving, Auditing, Lean Manufacturing and improving quality systems. Capable of fostering and maintaining positive working relationships with all levels of management.

Key Strengths include:

Skilled in Interpretation and Application of cGMP, QSRs, and GLP regulations

Validation / Formulations

Computer Aptitudes

Kaizen approach to continuous improvement

510K Submission

Project Management

Product Transfers

Six Sigma / Lean Manufacturing

Root Cause Analysis / Corrective Action and Preventive Action (CAPA)

Statistical Analysis/SPC

PROFESSIONAL EXPERIENCE

NATIVE RESOURCES GROUP/Clayton, NC June 2012-Present

Consultant Firms

HOSPIRA: Clayton, NC

Senior Project Specialist:( Clayton, NC) April 2014-Aug 2015

Review validation reports, Change Control documents, perform statistical analysis on product performance, conducted capability analysis for assigned products, conduct investigations, write APQR, and monitored product performance.

NOVARTIS, HOLLY SPRINGS, NC

Novartis, Holly Springs is the world’s first large-scale factory for producing flu vaccine using the techniques of cell culture.

Senior QA Specialist (Novartis, Holly Springs, NC) Sept.2013-April 2014

Support Quality functions for the Pernambuco QA group that will implement Supplier Qualification Program, assist with implementation of Quality Systems for Pernambuco site, and perform supplier/vendor audits as needed. Review and approve validation protocols (IFAT, IQ, OQ, and PQ) as well as create standard operating procedures for the Brazil site.

HOSPIRA: Clayton, NC

Hospira is the world’s leading provider of injectable drugs and infusion technologies. Clayton facility produces hospital products, including intravenous solutions, including large volume and small volume parenterals.

Senior Validation Engineer (Hospira, Clayton, NC) April-July 2013

Wrote and initiated PV and PQs validation protocols for the sterilization process for EVAC containers and Environmental Monitoring Cleaning Room Processes. Three month assignment.

Senior Quality Specialist (Hospira, Rocky Mount, NC) June-Dec 2012

Conducted complex investigations for OOS Laboratory failures, Small Volume Parental Departments for Labeling/Packaging, Aseptic Filling, Terminal Sterilization and Solutions.

Implemented Corrective Actions and Preventive Actions (CAPAs) that initiated facility wide glass breakage team that encompassed all areas of glass usage from incoming raw materials, transportation from R1 to R2, in process(filling, capping, stoppering, labeling, and packaging) through final product release.

Implemented Corrective Actions to add shield on Aseptic Filling Lines to contain glass breakage within the defined filling zones.

Implemented Corrective Action for Material Management to add tracking for Work In Process to prevent usage of expiry products and commodities.

Implemented Corrective Action for Terminal Sterilization to prevent labeling and handling issues.

Implemented Corrective Action in Autoclave area to install additional cameras to prevent product mix up.

Implemented Corrective Action to initiate an SOP that defines criteria for dealing with glass particulate

MARGARET HIRALDO Page Two

ACTAVIS PHARMACEUTICALS, Sunrise, Florida

The third largest global Manufacturer of Pharmaceuticals. Sept. 2011- June 2012

Technical Writer (Contractor)

Revise and Standardize Standard Operating Procedure to ensure compliance to the Code of Federal Regulations (CFR-21) for the Maintenance, Engineering, and Research and Development Departments.

WATSON PHARMACEUTICALS, Davie, Florida Sept 2006 – June2011

A $3.57B global manufacturer of Pharmaceuticals / Biotech and Medical Device products.

Process Engineer II (2009 – 2011)

Conducted complex investigations for OOS failures working closely with Managers of Pharmaceutical Technology to improve manufacturing processes.

Implemented Corrective Actions and Preventive Actions (CAPAs) that reduced quality defects for Out of Specification and Out of Tolerance Failures for a savings of $5M.

Initiated Study and Confirmation Protocols for process improvement projects to reduced quality defects that saved $100K.

Supervisor Quality Engineers (2008 – 2009)

Directed activities of four direct reports in Quality Investigation and Compliance (QIC), mentored, and trained. Provided Quality Council metrics and investigational updates to senior management.

Implemented form for capturing critical information needed to conduct investigations that reduced investigation turn over time by 15%.

Improved data system used to generate reports for Monthly Quality metric that reduced labor time by 10%.

Calibration Team Member that helped defined the criteria for reporting Out of Tolerance events for equipment calibration that reduced equipment downtime by 25%.

Saved $80K by determining root cause of raw material failure for Metoprolol Succinate 25mg / 50mg Tablets.

Received Watson’s Manufacturing Operation Award for delivering product inventory on schedule with no customer back orders.

Senior QA Engineer (2007 – 2008)

Perform investigation and generate CAPAs on deviation generated within manufacturing, QC, calibration, facility engineering, and maintenance departments.

Saved company over $240K yearly by implementing CAPA for Fluid Bed Granulators.

QA Engineer (2006 – 2007)

Perform statistical analysis on product performance, investigations, initiated CAPAs, monitor Quality Control Charts for three generic products, performed gage R& R studies, generated engineering changes for process improvements, conducted capability analysis for assigned products, and monitored product performance.

Implemented new SOP for Davie Site to improve operators’ knowledge of rounding and significant figures that reduced labor hours by 15%.

Core team member for compression team project that reduced equipment set-up by 50% and scale team member that identified types of scales needed for manufacturing areas and calibration cycles.

BOSTON SCIENTIFIC CORPORATION, Miami, Florida Nov. 2000 – Jan. 2006

The world largest Medical Device manufacturer with profits of $525B global.

QA Engineer II (2002 – 2006)

Generate engineering changes for process improvements and perform failure investigations, determine root cause analysis, determine corrective action and write internal complaint reports.

Led in-process improvements project for Six Sigma Green Belt certification.

Implemented two Value improvement projects that saved company over $250K.

Project Manager for Raw Material Critical Code Implementation for Non Cardiovascular Products that was instrumental in site recertification for ISO 9000.

Achieved Project Management Training Certificate .

Reduced product defects by 10 % for peripheral guide-wires

QA Engineer I (2000- 2002)

Write and approve validation protocol and inspection procedures, train inspectors in use and maintenance of equipment, tools, and procedures. Generate engineering changes for process improvements and perform root cause failure investigations.

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Initiated and approved process validations (IQ, OQ, PQ) for endoscopy guide-wire that allowed company to maintain customer inventory due to plant closure at Oregon site.

Participated in reliability and product development Team for Hydrophilic guide-wires that produced yearly $5M revenue for company.

Instrumental in transferring Hydrophilic guide-wire from R&D phase to Commercialization that initiated $5M yearly revenue.

Approved IQ, OQ and PQ Master Validation Protocols and reports for Hydrophilic Endoscopic guide wires from Research and Development stage through commercialization phase.

DADE BEHRING INC., Miami, Florida (Formerly Baxter Diagnostics, Inc.)

Dade Behring

The combined operations of the companies reached sales of $1.2 B and employed a workforce of 6,400 worldwide.

Prior to 1999:

Dade International was a private, independent company created by a group of investors who bought Baxter International's diagnostics unit for over $440M, in late 1994. The new firm became the world's largest company devoted to diagnostics, with sales of over $500M.

Various increasing job functions: Scientist I (Performed analytical and clinical chemistry testing on various instruments), Scientist II (Conducted Compliance Review for batch records and released Master Batch Records), Associate Research Scientist ( Reformulations, Clinical Trials, 510K submissions, Performed Complex Investigation through DOE, ), QA Supervisor (60% reductions in Raw Material Testing Cycle times, Reduced Raw Material Cost by 20%, Standardized In-Process Testing) Scientist, Field Quality Specialist (Wrote Customer Letter for Field Corrective Actions for FDA response).

EDUCATION

Master of Science (MS), Quality Management University of Miami, Coral Gables, Florida

Bachelor of Science (BS), University of North Carolina at Pembroke, Pembroke, North Carolina

TECHNICAL SKILLS

Minitab, Student Professionals Statistical Analysis (SPSS), SAP, Statement Auditing Standards (SAS),

Stat graphics, Computer Auto Drawing (Auto CAD), JD-Edwards Application, Stat Graphic, PDM, Qumas,

ISO 9001 Training, Auditor Training, Project Management Training, Team Leadership Training,

Diversity Training, SPC Training, Supervisor Training, Hardware & Laboratory Instrumentation,

Pharmaceutical Tablet Technology Training, Microsoft Office Suite: MS Word, MS Excel, MS PowerPoint,

MS Access, Snap Graphics, ISO-13485, ISOTrain, Hot Dox / Livelink, LIMS, TrackWise

PUBLICATIONS / CERTIFICATES / ASSOCIATIONS

Six Sigma Yellow and Green Belt Training

ISO 9000 Certified

Lean Manufacturing Training

ASQ Auditor and CQE Training Certificates

Project Management Certificate

Reformulated two products for Paramax Automated Clinical Analyzer and submitted 510(k) technical release documents

Co-authored four articles published in American Association for Clinical Chemistry (AACC)

Two Baxter Manufacturing Excellence Awards

Boston Scientific Quality Leadership Achievement Certificate

Member of National Association of Professional Women

Member of American Society of Quality (ASQ)

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