Project Manager Quality Control

Octavia White, MSc

Miami, FL *****

*****.*******@*****.*** Mobile: 954-***-****

Obtain a Regulatory Affairs position in a stable organization where I can

use organizational and project management knowledge and skills while

developing as an effective team member/facilitator within the organization.

. Experience in constructing pharmaceutical and medical device industry

US and BSI submissions /notifications, i.e.PMA, s/PMA, 30-Day Notice,

Express PMA, 510(k), and Design Dossiers per FDA guidelines.

. Experience in building templates and collecting documentation

deliverables for PMA, s/PMA, and 510k(s) in support of Class II/III

device submissions.

. Skilled in interfacing through conference calls and meetings with

various departments and personnel including IM, Product Definition

Management System (cPDM), New Product Development Team (NPD), R&D,

Engineering, Quality, Clinical, Records Management, Finance,

Consultants (PRTM) concerning submission deliverables.

. Improved regulatory submission process and tracking by developing MS

Project templates with reportable accountability of project phases,

activities, deliverable dates, and human resources associated with

each submission.

. Proficient in the use of MS Office Suite (i.e. MS Word, Excel, Power

Point, Access), Adobe Acrobat Reader/Editor, MS Project, Project

Workbench, SharePoint, Outlook, Internet research (WWW).

. Knowledge of FDA regulations and web searches, ICH/GMP Guidelines,

technical documents, and SOP development.

. Motivated, multi-tasking, organized, and detail oriented professional.

. Strong contributor to organization in a team environment as well as

work independently.

. Ability to work closely with people at all levels of an organization.

Master of Science, Clinical Research Administration

Walden University, Minneapolis, MN

Bachelor of Science, Major: Business Education

University of Georgia, Athens, GA

Associates of Applied Science, Major: Industrial Pharmaceutical Technology

Wake Technical Community College, Raleigh, NC

Certificate of Masters in IT Project Management

ESI Project Management Institute, Washington, DC

MS Office Suite (MSWord, EXCEL, Power Point, Access), Adobe Acrobat

Professional, MS Project, Project Workbench, Primavera, Documentum,

Outlook, Meditech, Kronos, SharePoint, Healthstream, Intranet e-room

environments, Internet Research (WWW)

Accreditation & Regulatory Coordinator (Contractor)

Miami Children's Hospital (MCH), Coral Gables, FL

11/2012-current

. Assist with the coordination of all Continuous Survey Readiness (CSR)

efforts at MCH.

. Analysis and data collection, tracking and trending of Joint

Commission data and observations.

. Assist in the investigation of Environment of Care (EOC) rounds and

other hospital accreditations and regulatory initiatives as needed in

preparation of CSR.

. Working knowledge of all Accreditation & Regulatory intranet sites,

i.e., Clinical Accreditation, Licensing, & Certifications, Focused

Standards Assessment (FSA), departmental Clean Sweeps Checklist, etc.

. Knowledgeable of Centers for Medicare & Medicaid Services (CMS),

Conditions of Participation (CoP), State Licensing Codes, and Joint

Commission Standards.

Physician Services Hospitalist Coordinator

Aventura Hospital & Medical Center, Aventura, FL

8/2011- 4/2012

Westside Regional Hospital, Plantation, FL

Aventura Hospital & Medical Center, Aventura, FL

4/2007- 6/2011

Executive Assistant to Chief Operating Officer/Ethics & Compliance Officer

Cordis (J&J Company) - Consultant, Miami Lakes, FL

5/2005 - 1/2007

PMO - Project Manager / Controller

. Develop regulatory submission templates to streamline submission

process to FDA, Japan, and Europe.

. Provide support to Regulatory Directors by designing MS project plans

for FDA, BSI and OUS submissions. Work closely with Regulatory

Directors, R&D team, and New Product Development team to gather

information concerning deliverables, dates, durations, resources as

well as track submission projects.

. Provide hands on support in the compilation, delivery, archiving, and

tracking of regulatory submissions in eCTD and paper formats.

. Research, design and implement e-room environment tool for project

team collaboration.

. Provide resource management database and support regarding all

projects with Regulatory pipeline.

. Research and gather requirements, design and implement software to

archive all regulatory documentation submissions, FDA correspondence,

meeting pre-materials and emails to electronic storage filing system.

Bayer Biological Products - Contract, Raleigh, NC

5/2004 - 5/2005

Sr. Documentation Specialist II / Business Analyst - Regulatory

. Design and implement Access database, reports and excel spreadsheets

to manage and track product submissions, registrations, legalizations,

certifications and dossiers for all Bayer Biological products.

. Revise Regulatory Affairs archived documentation system to improve

efficiency of upcoming submissions and reference materials.

. Provide support on submission audit team for all Regions of the World

(ROW) and U.S. submission documentation.

PBS&J Engineering - Contract, Raleigh, NC

4/2003 - 4/2004

FEMA Storm Debris Inspector

Wyeth (Vaccines and Pharmaceuticals) - Contract, Sanford, NC

9/2002 - 2/2003

Quality Control Lab Associate

. Quality Control of manufacturing sample log entries against label ID,

assign QC micro ID numbers, record entries and assign lab test reports

for proper QC testing to be performed.

. Assist with preparation and performance of internal audits to assess

the adherence of the SOPs, equipment files, cleaning schedules,

maintenance reports, equipment operation, and all log test records to

the approved and established procedures and requirements.

. Responsible for updating, running queries and reports in testing

database of all test results associated with samples.

. Perform peer reviews of laboratory and process control documentation

for accuracy, completeness and compliance to established procedures.

References available upon request

RELEVANT SKILLS

EDUCATION

SOFTWARE SKILLS

PROFESSIONAL EXPERIENCE

OBJECTIVE

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