Quality Assurance Project

* ****** ****

Dear Professional:

I provide exceptional leadership and health care project management services. I judiciously

manage, monitor and audit critical path projects. I am highly organized and flexible. I support

my colleagues and adjust myself to unexpected changes in deliverables and timelines. I design

innovative workflows to simplify and expedite business processes without compromising

quality.

In addition to effective project management, I author and substantively edit high quality

executive-level documents for approval and submission. With a cross-functional team of Subject

Matter Experts (SMEs), we collaboratively integrate information to create compliant validation

packages. I empower my colleagues to learn and grow and offer my best each day. I directly

discuss my challenges, and any setbacks, promptly and proactively. I complete my projects on

time and focus my efforts to attain aggressive personal and team stretch goals.

For some projects, I manage resources and for other early phase projects, I manage conceptual

designs and create business proposals. In other instances, I perform ad hoc audits to verify source

data for compliance. In many situations, I review validation criteria in order to audit business

protocols. I regularly apply six sigma tools and strategies in my business practices with my

customers and clients. I employ a methodical approach to troubleshooting, reason critically and

know when it is time to brainstorm with my team and how pausing to draw mind maps or even to

pace our team enhances innovative outcomes. My refined analytical abilities are transferable

across many industries: Information Technology, Biotechnology, Medicine, Science and

Business.

Please notice that thus far I have successfully completed five semesters of medical school

business school in parallel. With great leadership and support, I designed a strategic plan to

integrate my studies in the field following my fifth semester of medical school. In these

programs, I analyzed the Affordable Care Act across and within healthcare organizations:

Information Management, Accounting, Finance, and Law. I plan to offer stated professional

services for at least 18-24 months.

In addition to my broad professional experience, I enjoy recreational bicycling and international

travel. I am environmentally responsible, active in my community and participate in international

medical mission projects. I continually challenge myself to grow personally and professionally.

My highest purpose is to serve -- as a uniting global force for improved health and well being in

the world.

Sincerely,

Rebecca Kubin

**********@*****.***

650-***-**** (mobile)

REBECCA JANE KUBIN

**********@*****.*** 650-***-****)

EXECUTIVE SUMMARY

IT IMPLEMENTATION STRATEGIST, HEALTHCARE MANAGEMENT

Strategize and administrate document change control functions. Advocate business

decisions that support project time lines, deliverables and corporate goals. Collaborate

with advisory board representatives, subject matter experts and management team to

simplify workflows to scope crush. Accelerate productivity by empowering team to

proactively deliver. Troubleshoot discontiguous priorities and manage risks to increase

return on investment. Conduct video and teleconferences. Schedule company-wide

training modules and seminars to introduce new functionality to stakeholders.

2007-2013: Tertiary Education

Master of Business Administration, Healthcare Management

(Expected Graduation: 2013)

Medicine MD1-MD5, USMLE Step I Board Eligible

(Expected Graduation: 2016)

2004-2007: Biotechnology Project Management - Regulatory, QA, IT, Facilities

2002-2004: Editing and Writing - Medical, Clinical, Technical, Scientific (<2004)

<2002: Analytical Chemistry - Quality Control, Development Engineering,

PROFESSIONAL ACHIEVEMENTS

SENIOR PROJECT MANAGEMENT (2007-2004)

GILEAD SCIENCES, FOSTER CITY, California (7/2007-11/2007)

Senior Manager, Regulatory Affairs - CMC. Lead business user administration with

implementation of regulatory submission tracking database. Managed data migration and

training resources. Conducted teleconference for global affiliates. Edited and published

user guide. Presented core curriculum to international clients.

GENENTECH INC., South San Francisco, California

(multi-departmental: 1/2007-7/2007).

Project Coordinator (POC), it project management coordinated, and monitored and

tracked document change control procedures across multiple sites and business units.

Reported directly to Senior CIT project manager. Collaborate with QA change control

and business process owners to expedite document review and approval.

GENENTECH INC., South San Francisco, California (see above entry: 1/2007-7/2007)

Managed and coordinated quality assurance document change control process. Supported

Quality Assurance, IT and Facilities Management manage controlled-document databases.

ELAN PHARMACEUTICALS INC., South San Francisco, California (2006)

Edited and processed entire suite of toxicology reports for regulatory submission of

Tysabri. Reported to senior director and pharmacologist while reporting to the vice

president of research and development. Managed schedules and change control Senior

Scientists

REBECCA JANE KUBIN

**********@*****.*** 650-***-****)

GENENTECH INC., South San Francisco, California (2005)

Authored, edited and revised all standard operating procedures and department controlled

documents. Quality Assurance POC for CIT and logistics for SAP implementation.

GENENTECH INC., South San Francisco, California (2004-2005)

Authored, edited and revised standard operating procedures, standard records and

engineering specifications. Supported quality assurance change control for packaging and

materials.

DEPOMED, INC., Menlo Park, California (2004)

Authored regulated system documents and templates. Conducted final review of

regulatory documents for FDA submission packages. Audited notebooks and reports of

Phase I and Phase II clinical data for accuracy and consistency. Edited electronic

revisions to regulated corporate documents during final approval process.

EDITING - MEDICAL, CLINICAL, TECHNICAL, SCIENTIFIC (<2004)

STANFORD HOSPITALS AND CLINICS, Stanford, California (Contract)

Edited instructional materials for senior faculty in Surgical Pathology Department,

Stanford Medical School. Edited scientific publications and instructional materials for

medical school lectures. Transcribed faculty recommendations after graduate application

interviews.

STANFORD UNIVERSITY SCHOOL OF MEDICINE, Stanford, California

(Employee 1997)

Edited research proposals for Principal Investigator in Stanford Medical School Center

for Disease and Prevention (SCRDP).

UCSF RADIOLOGY DEPARTMENT, San Francisco, California (Contract)

Authored radiology documents to support new imaging system. Collaborated with

Engineers, System Administrators and SMEs to review functionality for document

content.

GENENTECH INC., South San Francisco, California (Contract)

Edited Herceptin (HER2) IND and BLA submission reports for Recovery Sciences Ph.D.

Scientists.

ALZA CORP., Mountain View, California (Contract)

Conducted HPLC validation testing. Authored summary reports for Development

Engineers.

GENENTECH INC., South San Francisco, California (Employee 1999-2002)

Managed production of SDLC validation packages in Medical Affairs (Clinical, Drug

Safety, Statistical Programming). Managed resources, deliverables and time lines for IT

system upgrades and implementation projects.

STANFORD HOSPITALS AND CLINICS, Stanford, California

(Per Diem: holidays, weekends, shift coverage. 2002-2003)

Captured electronic medical records using Cerner to integrate medical records,

computerized physician order entry (CPOE) and AR. Maintained the highest level of

quality patient care with professionalism, diplomacy and confidentiality.

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REBECCA JANE KUBIN

**********@*****.*** 650-***-****)

ANALYTICAL CHEMISTRY (<2002)

ALZA CORP., Mountain View, California (Contract) Authored analytical development

procedures. Tested HPLC instruments. Conducted IQ, OQ, PQ testing on new and legacy

HPLC instruments. Revised HPLC Standard Operating Procedures for Development

Engineering.

SEQUUS PHARMACEUTICALS Menlo Park, California (Employee 1993-1997)

Research Associate (I and II), Quality Control Analytical. Performed chromatographic

assays on chemotherapeutic drug substances. Reviewed proprietary laboratory notebooks

and QC training records with FDA Agents. Authored NDA Amendment for Doxirubicin.

GENENTECH, INC., SO. SAN FRANCISCO, CA (Contract)

Quality Control Analytical Chemist, Marketed Products. Performed analytical assays:

rTPA, hGH and marketed products during in-process testing.

TERTIARY INSTITUTIONS

Masters Degree in Business and Healthcare Management, Davenport University (2013)

Atlantic University School of Medicine, Long Island, New York (2012)

Bachelor of Arts, Psychology, University of California, Berkeley, California (1991)

CERTIFICATION AND LICENSURE

Advanced Preclinical Review Program: USMLE Step I Medical Licensing Exam

(Aug 2012)

Basic Life Support for Healthcare Providers, AHA, Chicago, Illinois (May 2012)

Project Management, Project Management Institute, San Francisco, California

(Nov 2007)

EMT-Basic; First Responder First Aid, EMS Academy, Redwood Shores, California

(Dec 2006)

Post Baccalaureate, Pre-Medicine, Notre Dame de Namur, Belmont, California

(May 1997)

SERVICE

Publication - Faculty Selection For Medical School Magazine

Community Achievement Project - Hurricane Omar Relief Project, Saint Christopher

Stanford Cancer Center, Navigator - Stanford, California, United States

International Medical Mission Project, Prescription Translation - Managua, Nicaragua

International Vaccination Project - Santo Domingo, Dominican Republic

International Dental/Public Health Project, Hidalgo, Mexico

Samaritan Medical Community Clinic, San Mateo, California

Organic Chemistry and Physics Tutor - Notre Dame De Namur University, Belmont, CA

California United States Air Force ROTC - Commandants Award, U.C. Berkeley

AFFILIATIONS

American Medical Student Association, AMSA

Cal Alumni Association, University Of California, Berkeley

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