Quality Assurance Management

Erika C. Green

** ***** ******, **********, *** York 10927

(C) 845-***-**** • (H) 845-***-**** • ab9kuu@r.postjobfree.com

PROFESSIONAL PROFILE

Steady 10 year history in pharmaceutical industry with experience in both Research and Manufacturing

divisions. Support colleagues in process improvement throughout various departments, including Quality

Assurance, specializing in document control.

EDUCATION

Master of Business Administration, Operations Management Specialization, 2013

American InterContinental University, Schaumburg, Illinois

• Relevant coursework: Strategic Management, Quality Management and Continuous Improvement,

Business Research for Decision Making, Operations Management for Competitive Advantage

Bachelor of Business Administration, Operations Management Concentration, 2010

American InterContinental University, Schaumburg, Illinois

• Relevant coursework: Business Communications, Concepts in Organizational Behavior, Production

Planning and Quality Management, Operations Management Principles

EXPERIENCE

Quality Assurance Document Coordinator, 2013-Present

Becton Dickinson Diabetes Health Care Research and Development, Franklin Lakes, New Jersey

• Issue document numbers to engineers for creation of documentation for research and other information

• Modified filing system which brought about ease of access, standardization, and better organization, as

well as verifying accuracy and GMP regulations followed at check in

• Took on responsibility for process flow of documents in review and approval circulation, thus allowing

management to focus on other project details and maintaining organization in process

• Circulate documents in QDMS for review and approval to ensure that projects are approved and

executed in timely manner

• Scan documents for electronic archival to ensure enhanced organization and ease of access for

engineers and quality specialists

• Prepare documents in various folders and Excel spreadsheets in support of project for moving from

paper based system to SAP system for accurate standardized electronic archival

Operations and Strategy Records Management Associate Records Custodian, 2011-2012

Vaccine Research East and Early Development, Pearl River, New York

• Created standardized system of issuing and reconciling lab notebooks and equipment logbooks, creating

easy access and accurate tracking along with missing notebooks and logbooks not previously found

• Logged in and checked data packages for archival and verified accuracy of data at check in

• Performed inventory of sealed and non-sealed documents in records room, thus confirming documents

had been filed correctly and data had been entered accurately

• Prepared lab notebooks for offsite storage by scanning and recording research information to help with

true record retention, alleviate physical onsite space, and create access for scientists to reference

material

Quality Assurance Records Management Document Coordinator, 2007-2011

Pfizer Biotechnology, Pearl River, New York

• Created new system and protocol document ID numbers so specialists had unique identifiers for

documentation to write and execute

• Performed research through Valhalla database to recover information and generate reports for inquiries

as requested by staff for referencing and inventorying to ensure records were retained accurately and

consistently

• Supported various departments within Vaccines Manufacturing and Consumer Health with records

management, retrieving documents or requested information to aid in audits

• Authored SOPs for QA Records Management job functions and trained staff to ensure defined

performance of job duties, team development, and sharing of best practices

• Revised documents into SRC format to eliminate errors and ensure accuracy in compliance with FDA

standards

Documentation Specialist, 2003-2007

Wyeth Vaccines and Pediatrics, Pearl River, New York

• Researched controlled documents to retrieve data in order to add to or correct existing information,

promoting ease of access for engineers and validation specialist to valuable data

• Scanned controlled documents for offsite storage and enhanced security of documents

• Circulated documents and tracked for validating and approvals to ensure timely approvals and better

process flow of documents in circulation

• Performed test execution on IOQ and PQ protocols for validation of Valhalla system and VPM to be

utilized for faster more accurate record retention

Validation Documentation Technician/Documentation Specialist, 2003

Wyeth Pharmaceuticals, Pearl River, New York

• Performed numerical and alphanumerical filing and archiving as well as data entry into several

proprietary databases, promoting ease of access to approved reports for engineers and quality

specialists

• Checked scanned materials for completeness and clarity to ensure all important material was included

for future reference

TECHNICAL SKILLS

Operating Systems: Windows 98, 2000, 2003, 2007, Vista, 2010, Novell

Software: Office, Adobe, GroupWise

Databases: Valhalla, ISOTrain, GXPharma, Procite, QDMS

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