Manager Management

PORFIRIO S. RAMIREZ

*** *. ****** ***. ***************@*********.*** Home: 312-***-****

Chicago, IL 60612 Cell: 773-***-****

SUMMARY OF QUALIFICATIONS

A bilingual (proficient in written and spoken English and Spanish), innovative, Operations

professional with extensive experience in manufacturing systems within FDA-regulated industries;

Proven expertise with all chemical processing equipment, process improvement, and finding low-

cost, practical, real-world, workable solutions; Problem-solving team player who interacts

effectively across all levels of an organization.

PROFESSIONAL EXPERIENCE

ORGANICS, LLC (A subsidiary of Solvay Pharmaceuticals, Inc.) 1991 – Present

Active Pharmaceutical Ingredient (API) manufacturer for Conjugated

and Esterified Estrogens.

Operations Manager July 2008 – Present

Responsible for performing IQ/OQ protocols, management of calibration activities for all

Production, R&T and QC equipment as well as all Operation Specialist responsibilities

Accomplishments:

• Became responsible for all IQ/OQ protocols and calibration activities after two employees

resigned. This allowed the organization to manage through attrition by not needing to hire

replacements.

• Created calibration specification sheet for contract calibration technicians to reference set

points and tolerances. This helped align our requirements with calibration vendor. They

expressed this was a good way to convey future changes. This helped reduce the QA

certificate review time (fewer discrepancies discovered after calibration technicians left.)

• Reduced length of down time by 25% to complete calibration of all equipment. Better

organization and preparation of equipment led to this reduction.

• Developed system to introduce water for cleaning equipment in containment room without

exposure to active powders. Resulted in better containment in common area of potent

powders.

• MESO Team Member (Manufacturing Equipment Systems Organization) – As team

member completed stock sheet creation 8 weeks ahead of schedule and used stock sheets

to create master records in Calibration Manager data base, again, completing 8 weeks

ahead of schedule. This allowed calibration activities to start on time and led to full on time

project implementation.

• COQUI Team Member (Cost of Quality Improvement) – Participated on team to redesign

transportation activities between warehouse to manufacturing facility. This led to annual

savings of $32,000.00

Operations Specialist November 2001 – July 2008

Responsible for updating outdated equipment systems with new technology through the

management of change system, in addition to working with Research and Development to

develop new products and services; Liaison between manufacturing site and corporate offices, by

assisting production increase efficiency and maintain cGMP compliance, and working with Quality

Assurance to resolve production related investigations.

Accomplishments:

• Led project to build new production facility

o Developed process flow diagrams of old and proposed system

o Determined equipment needs to fit three budget scenarios

o Worked with equipment vendors to determine best equipment

• Implemented an electronic preventative maintenance system, eliminating more than 100

paper maintenance records, along with over 100 paper reminders

Porfirio S. Ramirez Page Two

• Replaced outdated still produced water system with a modern DI water system, allowing

water to be available immediately for production use. Old still system required one day to

manufacture water

• Won 2007 Summit Award and President’s Award for Excellence for developing and

implementing low cost (<$50) technology and procedures reducing employee exposure to

potent powders by 90%. Also, finalist for 2007 Pioneer Award for Innovation for this.

• Improved GMP compliance and production process logistics by observing production

personnel and, making and implementing recommendations. This eliminated hours of

setup time for each batch.

Production Supervisor June 1995– November 2001

Supervised pharmaceutical Production Operators and Technicians by scheduling work

assignments, supervised batch reactions, and performed personnel evaluations; Assured

GMP/FDA regulations were followed.

Production Operator February 1991 – June 1995

Performed sterile fill and lyophilization operations, along with distillations and wet granulations;

Assisted in developing Batch Production Records and Standard Operating Procedures and

performed troubleshooting and maintenance on production equipment.

ADDITIONAL WORK EXPERIENCE

Zenith - Phosphor Process Technician

MDA Scientific, Inc. - Chemical Batch Operator

BARR Company - Chemical Operator

G.D. Searle Company - Pilot Plant Technician/Operator

Diamond Shamrock Corporation - Supervisor/Operator

EDUCATION

North Park University Chicago, IL

Bachelor of General Studies, Magna Cum Laude Graduated May 2006

Major: Organizational Management

CERTIFICATIONS

Six Sigma Green Belt Certification,

including Lean Manufacturing and Design for Six Sigma August 2009

PROFESSIONAL DEVELOPMENT

• Management Development Series Training – In house Manager Training including Roles of

Manager, Performance Management, Selecting, Building, and Retaining Talent

ADDITIONAL SKILLS AND TRAINING

• Proficient

in the following software:

Visio

o

Turbo Project – Project Management Software

o

Blue Mountain – Calibration Manager

o

QUMAS – Electronic Documentation Management Software

o

Trackwise – Electronic Tracking System for tracking deviations, investigations,

o

and change control

• Knowledge of Statistical Process Control

Contact this candidate