ALLA TERESH

TEANECK, NJ 07666 ALLATERESH@GMAIL.COM (201)914-0019

SUMMARY OF QUALIFICATIONS
A certified Quality Assurance Professional with nine years of document control supervision experience, specializing in database (electronic and physical) creation and management in compliance with FDA regulations and ISO standards.

DEMONSTRATED COMPETENCIES
Designed and implemented a document control system for a startup company that was audited for and awarded an FDA medical PMA and 510K, bringing out the worlds first FDA approved automated melanoma detection device, and CE Mark approval for distribution in Europe.

INDUSTRY CERTIFICATIONS American Society of Quality, Certified Quality Auditor WORK EXPERIENCE Awarded December 2011 May 2004 Present

Document Control Supervisor

MELA Sciences, Inc.

Created and managed document control for MELAs quality system documentation, to ensure compliance with FDA and European Union laws and regulations. Earned two promotions: from Document Control Officer to Quality Assurance Specialist, August 2009, and from Quality Assurance Specialist to Document Control Supervisor, December 2011. Earned the Employee of the Month Award in August 2011 from the company CEO. Quality and Regulatory Control: Designed and created Quality System Document Control Procedures and organization. Managed and maintained over 5-K controlled quality, regulatory, clinical and project files in the restricted access Document Control Center (DCC) and the Quality Assurance database, using MS Excel and the SVN repository. Analyzed Quality System documentation for completeness, inaccuracies, redundancies, and consistencies to ensure regulatory compliance. Created and managed and maintained appropriate top-level electronic directories, associated folders, subfolders, and files and established permission policies on a public server computer managed by QA/RA. Created and operated a Microsoft Excel-based document control system and distributed controlled documents internally and to third parties. Supervised and directed Document Control Administrator, whose responsibilities included tracking, distributing and maintaining controlled documentation. Created and managed the Master Document Numbering Log, which included lists of current documents with document numbers, titles, revisions, dates of approval, histories, and change request numbers. Managed the control and distribution of (approximately) three approved change orders and the processing of 100 documents per day. Coordinated Change Order (CO) process document analysis, editing, and approval with all seven company departments. Ensured all change orders were implemented according to the change procedure by assigning numbers and tracking and reviewing requests in coordination with the initiator, Department Managers, and owners. Maintained minutes from project, quality group, risk management, change request, and design review meetings. Maintained the hard and electronic copies of the MelaFind External List of requirements and standards. Record and Information Management: Key member of team responsible for the preparation, editing and publication of PMA documentation comprising 162 binders, as submitted to FDA. Prepared key documentation and information to support BSI and FDA audits, and participated in audit interviews, ensuring the success of BSI and FDA audits, leading to MELA earning approval to sell products in EU member nations and the U.S. Managed the Design History File (DHF) and Device Master Records (DMR) in digital and hard copy formats. Provided technical review for quality documentation, including engineering drawings, change requests, training records, Device History Records (DHR), calibration records, Design History Files (DHF), FDA

ALLA TERESH
TEANECK, NJ 07666 ALLATERESH@GMAIL.COM (201)914-0019

correspondences, deviations, and Non-Conformance Records (NCR). Maintained the 49-member Approved Vendor List (AVL). Maintained and monitored employee training records for between eighty and ninety staff. Supervised instrument calibration program for over thirty instruments, including maintaining calibration records and the master calibration log, and notifying appropriate Engineers of uncalibrated instruments.

EDUCATION

Web Development & Business Programming Diploma

The CHUBB Institute

Awarded April 2002 Parsippany, NJ Minsk, Belarus February 1998 April 2004 Hackensack, NJ October 2009 Present

Bachelor of Arts (B.A.), Secondary School Education Mathematics

A.M. Gorky Minsk State Pedagogical Institute ADDITIONAL WORK EXPERIENCE

Home Health Agent

Care Finders Inc. ASSOCIATIONS American Society for Quality (ASQ) TECHNICAL SKILLS

Software: Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Power Point, Adobe Acrobat, Microsoft Visio, AutoCAD Web Design: Visual Basic, C/C++, JavaScript, Java, Oracle. Engineering: Drafting Technical Drawings, Computer Aided Drafting (CAD) Quality and Regulatory Requirements: FDA Quality System Regulations (QSR), ISO 13485, ISO 9001, European Union Medical Device Directives (MDD) Languages: English, Russian - fluent

TRAINING
Paton Professional, Improve Your Audit Checklist, October 2012 Paton Professional, Conducting Successful Audit Interviews, September 2012 Heartsaver CPR AED, Member of First Aid Team at MELA Sciences, September 2012 The Center for Professional Advancement (CFPA), Implementing Supplier Audits, September 2012 The Center for Professional Advancement (CFPA), Documentation Management and Control, September 2012 Quality WBT Center for Education, Auditing (CQA) Fundamentals I, II, and II January 2011 American Society For Quality (ASQ), Certified Quality Auditor, November 2009 The Center for Professional Advancement (CFPA), ISO 13485, ISO 9001 and QSR Regulations, September 2008 Advanced Medical Technology Association (AdvaMed), Essentials of Medical Device Regulations, June 2008 SAI Global, Risk Management/Risk Analysis for Medical Devices Training, September 2007 The Center for Professional Advancement (CFPA), Documentation Management and Control, September 2005 The Center for Professional Advancement (CFPA), The Quality System, August 2004