Quality Assurance Management

Resume

CAREER SUMMARY

Results-driven and highly skilled management professional with 20+

years of experience in quality assurance for numerous manufacturing

processes. Expertise in analyze, assess and develop plans to assure

robust quality systems are in place to support continuous improvement.

This expertise includes knowledge in industry regulations,

establishment of robust quality policies and procedures, as well as

focus in people's knowledge and motivation.

Skills

. Regulatory compliance

. Quality Assurance

. Strategic planning

. Process improvement

. Team leadership

. Training and development

. Auditing and analysis

. Six Sigma Green Belt/Lean Principles

Core Accomplishments

. Developed a controlled forms' system that was used to develop the

automated system.

. Reduced the cycle time for batch disposition from 99 days to 39 days

in six (6) months.

. Developed an internal surveillance program named Quality2, intended to

develop a cross-functional process to self-audit our processes in

search of improvements.

. Led Plant Disaster Recovery Plan after Hurricane George in Amgen,

P.R., returning to production in a fast and reliable way.

. Support the preparation of a Quality Foundations and Intermediate

Skills Program as a Subject Matter Expert

. Effectively implemented a Quality Assurance-on-the-floor program

. Effectively developed and facilitated a Department Review program,

evaluating the state of the quality systems (changing from reactive to

proactive).

. Collaborate in the decommissioning process of a company.

Experience

Ben Venue Laboratories May 2012 -

Present

QA Senior Manager - Quality Assurance Operations

. Lead all Quality Assurance activities in the new manufacturing building

including: QA on the floor auditing, investigations (including CAPAs

and change control), batch record review, validation and projects'

support, GMP documentation approval, assure personnel is trained and

executing in a compliance environment, lead the quality oversight, lead

regulatory activities, among other responsibilities.

. Assure a robust process for technology transfers and ANDAs from the

existing facilities to the new facility.

. Provide quality oversight under the consent decree process, developing

and supporting the remediation plan and execution.

. Selected to work in the decommissioning/wind down team due to the

closure of operations.

Amgen Manufacturing, Inc. December 2003 -

May 2012

QA/QC Senior Manager

. Lead quality activities in site and factory levels related to: sampling

activities related to Clean Utilities, Environmental Monitoring and

process samples; qualifications, requalification, shutdown and non-

routine activities that require sampling strategies to validate / re-

validate manufacturing areas.

. Develop a new Quality Assurance team responsible of the Change Control

Program (authorization and approvals), Validation support (review and

approval of protocols, reports, etc.), Projects (from commissioning to

qualification), New Product Introduction Team member; revise/approve

all GMP documents of the facility.

. Responsible of the deviations/investigations management, Work Orders

system, Environmental Management System (EMS), Building Management

System (BMS) and Process Control System (PCS) alarms investigations,

keep metrics of these systems and prepare monthly and quarterly reports

to the top management, Environmental Characterization for new

buildings, support statistical process for monitoring initial and

routine programs.

. Support all regulatory audits (FDA, EMA, ANVISA, Canada, Japan, Korea,

Saudi Arabia, Mexico)

International Scientific-A, Inc. Nov 2001 - Nov 2003

Validation Project Leader

. Lead validation projects assigned to the company, including management

of personnel, preparation of proposals, and other management

responsibilities.

. Prepare and execute validation protocols and reports based on the

client needs related to parenteral and non-sterile environments, from

formulation to packaging areas (equipment and process).

Amgen, Puerto Rico

July 1992 - May 2001

QA/QC L Supervisor

. Coordinate sampling activities for the Environmental and Clean

Utilities Systems, including laboratory results receiving, filing or

delivery to customer (using Laboratory Information Management System

(LIMS)); shipment of samples for outside laboratories, for release

testing, stability or special testing.

. Lead the Gowning Certification Program, including scheduling, final

assessment, etc.

. Provide conditional and final release to systems after shutdowns,

before production

. Lead activities relate to lot final disposition, including

facilitating meetings, documentation flow; batch records reviews

. Lead on-the-floor audits, documentation audit and final cGMP

verification.

. Coordinate activities related to data trending for EM, Utilities and

gowning monitoring, management of Notice of Events (investigations),

and archiving of all laboratory reports.

. Direct support to the site regulatory approval (FDA and EMA), and

support Canada's audit.

Ortho Pharmaceutical, Manat , P.R. 1991 - 1992

Quality In-process Auditor

Ortho Biologics, Manat , P.R. 1989 - 1991

QC Microbiology Analyst

Education

. Management, BS, Kaplan University (December 2010, 4.0 GPA)

. Biology, Major, University of Puerto Rico, R o Piedras (1980-84)

. Chemistry and Mathematic, Minor, University of Puerto Rico, R o

Piedras (1980-84)

Professional Development

. Lean Principles Certification (Purdue University) (March 2014)

. Six-Sigma Green Belt Certification (Purdue University) (May 2012)

. Risk Management Training (PDA) (September 2013)

. Operational Excellence Concept (Amgen, 2011)

. Mentoring Program (Amgen, 2008)

. PDA / FDA Aseptic Guidelines Training (2000)

. Harmonization Project (ISO and FDA) (1998)

. Kepner Tregoe Problem Solving Training (1997)

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