Document Control Management, Audit

Document Control Manager

Focus of Interest: Medical Devices, Pharmaceutical, and Biotechnologies

[pic] Qualifications Profile

Concept-to-execution, detail-oriented, and certified quality auditor,

offering comprehensive experience in documentation audit and management

within medical device, pharmaceutical, and biotechnology companies.

Solutions-focused and team-oriented leader with outstanding involvement in

developing and implementing advanced strategies. Equipped with excellent

ability to accurately determine clients' needs while recommending solutions

and alternatives to current situations. Known for articulate communication

and interpersonal skills; with the ability to establish and sustain

positive working connections with diverse individuals and management at all

levels. Bilingual in English and Russian.

[pic] areas of expertise

Knowledge of Medical Device Regulation and Standards (e.g.,21 CFR 820,ISO 13485, EEC Medical Device Directives)

Quality Assurance Management and Audit

Project and Program Management

Change Order Process Management

Continuous Process Improvement

Key Documentation Administration

Conflict and Issue Resolution

Staff Training and Development

[pic] RELEVANT experience

MELA Sciences, Inc. (formerly known as Electro-Optical Sciences Inc.) (

Irvington, NY

Document Control Supervisor 2011-2015

Quality Assurance Specialist 2009-2011

Document Control Officer 2004-2009

< Handled all aspects of companywide change order process; control quality

and regulatory files maintenance in the document center; quality system

documentation assessment for completeness, inaccuracies, redundancies,

and inconsistencies.

< Leveraged skills in conducting technical reviews and in supporting the

creation of quality system documentation; including but not limited to

engineering drawings, manufacturing procedures, guidance documents, and

field service manuals, promotional literature, clinical documentation,

Device History Records (DHR), FDA and Notified Body correspondences,

deviations, Non-Conformance Records (NCR), and software documentation.

< Capitalized on keen attention to detail in overseeing top-level

electronic file directories, associated folders, subfolders, and files,

and establish permission policies on a public server computer managed by

the Quality Assurance and Regulatory Affairs (QA/RA) Department.

< Carried out internal and external audits, acted as the company lead

auditor, including monitoring employee training programs with records for

80 to 90 employees.

< Rendered leadership and support to the document control administrator and

intern(s).

Career Highlights

V As a key member of the project team, facilitated the launch of the

company's breakthrough medical technology MelaFind , world's first

analysis system for early detection of melanoma.

V Played a pivotal role in a team overseeing the submission of PMA

documentation.

V Fulfilled key roles during FDA and Notified Body (British Standards

Institute, BSI) audits, taking on tasks including the preparation and

provision of key documentation to support audits with the following

accomplishments:

< Enabling the company to receive CE Certification and FDA approval

to distribute its medical products in US and Europe

< Obtaining recognition from external auditor for outstanding

performance as the sole person doing tasks usually accomplished by

entire departments in other organizations

< Earning promotion to document control supervisor with a document

control administrator as a direct report.

V Received commendation from the company CEO with an Employee of the

Month Award in 2011.

V Earned recognition for notable contributions to the company including

the establishment of a document control system; quality system document

control procedures; and establishment of the instrument calibration

program for more than 30 instruments.

V Expedited the change order process toward completion by reviewing,

editing, and approving each controlled document prior to final

approval.

V Efficiently and singlehandedly managed the document control numbering

system for the entire company.

V Authored a software quality database, which subsequently served as the

software design history file during Food and Drug Administration (FDA)

audit; which found control of software distribution and tracking to be

adequate.

V Instituted a documentation system using Microsoft Excel spreadsheets to

create databases for logging and monitoring documents; including the

master document numbering log, covering the device master record (DMR),

design history file (DHF), change orders, calibration, and software

quality documentation.

ComplianceOnline ( Palo Alto, CA, USA

Instructor

[pic] oTHER experience

Care Finders ( Hackensack, NJ, USA

Home Health Agent

School #31 ( Minsk, Belarus

Math Teacher (Middle School and High School)

[pic] Education

The CHUBB Institute ~ Parsippany, NJ, USA

Web Development and Business Programming Diploma

Bergen Community College ~ Paramus, NJ, USA

Relevant Coursework:

Introduction to Information Technology ~ Microsoft Excel ~ Microsoft

Advanced Excel ~ Microsoft Access ~ Microsoft Office

Internet Research and Data Handling ~ Programming Logic ~ Java ~ C and C++

Programming ~

Drafting Technical Drawings ~ Computer Aided Drafting (CAD)

A.M. Gorky Minsk State Pedagogical Institute ~ Minsk, Belarus

Bachelor of Arts in Secondary School Education, Major in Mathematics

[pic] credentials

American Society for Quality: Certified Quality Auditor

[pic] professional development

Complianceonline.com: Elements of an Effective Change Control System

Medical Device Summit: The Quality System Regulation (QSR)

Paton Professional: Get Tough on Correction Actions ~ Controlling

Nonconforming Material ~

Improve Your Audit Checklist ~ Conducting Successful Audit Interviews

Heartsaver: Cardiopulmonary Resuscitation (CPR) Certification ~ Automated

External Defibrillator (AED) Certification

The Center for Professional Advancement (CFPA): Documentation Management

and Control ~

Implementing Supplier Audits ~ ISO 13485, ISO 9001, QSR Regulations ~ The

Quality System

Quality WBT Center for Education: Auditing (CQA) Fundamentals I, II, and II

Advanced Medical Technology Association (AdvaMed): Essentials of Medical

Device Regulations

SAI Global: Risk Management and Risk Analysis for Medical Devices Training

(ISO 14971)

[pic] professional Affiliations

American Society for Quality (ASQ)

[pic] technical acumen

Software Microsoft Office Suite (Word, Excel, and PowerPoint)

Applications Microsoft Access ~

Adobe Acrobat ~ Microsoft Visio ~ AutoCAD

Web Design Visual Basic ~ C/C++ ~ JavaScript ~ Java ~ Oracle

Engineering Programs Drafting Technical Drawings ~ Computer Aided Drafting (CAD)

Documentation Design History File (DHF) ~ Device Master Record (DMR) ~

Calibration Program

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