Quality Assurance Management

Janet Wilson Chung-Ying

*** ******* ****

Freehold, NJ 07728

732-***-**** Cell

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

Documentation manager with 10+ years of expertise in document control in an

FDA regulated environment, 5+ years experience working in an Information

Management Quality Assurance environment

SUMMARY OF QUALIFICATIONS

. Managed a staff of 6 to 8 technical writers

. Authored and revised, regulated documents such as, Clinical Safety

Reports, Product Development Reports, SDLC/ Validation Documents,

SOPs, Work Instructions, Policies, User Manuals and specifications.

. Created internal business communication documentation

. Authored Business Continuity Plan

. Developed and established the business processes to create and manage

controlled documents

. Developed the change control system to revise and release controlled

documents.

. Established training program and trained staff on document control

processes and procedures.

. Managed and implemented changes to documentation process across BMS

organizations.

. Managed documentation creation, revision and distribution process.

. Managed documentation projects in a cross functional environment.

. Established and managed documentation library.

. Managed the EDMS (document management system)

. Reviewed business processes, facilitate meetings to develop/streamline

business processes.

. Performed quality assurance review and approval of controlled

documents

. Performed gap analysis of Design History files and created

documentation to remediate gaps.

. Analyzed and summarized complex scholarly, research and technical

materials

TECHNICAL SKILLS

. Excellent Working knowledge of document management in a FDA regulated

environment

. Excellent skills in process mapping, writing and editing documents,

such as SOP, and Policies

. Good Working Knowledge of 21 CFR Part 11, 21 CFR Part 820, 21 CFR Part

211 regulations, System Development Life Cycle (SDLC), GXP systems

. Proficient in Microsoft Word, Excel, Project Management, PowerPoint,

Acrobat, Visio

. Proficient in Documentum Systems such as GxPharma, DCM5, PICASSO

. Working knowledge of Remedy and FieldGlass, Sharepoint

. Experienced in Business Process Reengineering and Project Management

. Excellent mentoring skills to facilitate growth and development of

employees

. Familiar with Drug Development process and ICH Guidelines

PROFESSIONAL EXPERIENCE

Technical Writer (Consultant with Cost Management November 2008 to December

Incentive, Inc) 2009

Johnson & Johnson, Consumer Products Worldwide Skillman, NJ

. Wrote Safety Summaries and Product Development Summaries for Consumer

Products Division

o Reviewed research and development information including clinical

and pre-clinical protocols and study reports, analyze and

summarized data to create the Safety Summaries

o Reviewed development information such as: Marketing and Consumer

Use Test Results, stability studies etc. and created the and

Product Development Summaries

. Reviewed Design History Files for Class 2 medical devices for

compliance with to J&J Standard Operating Procedures, 21 CFR Part 820,

Quality Systems Regulations.

. Review included:

o Evaluation of the DHF to ensure compliance with J&J procedures

o Reviewing the documentation collected during each phase of device

development to ensure proper documentation was created.

o Reviewing existing documents for good documentation practices and

control

o Reviewing internal audit findings

. Created and recommended the DHF Index

. Participated in meetings with subject matter experts to discuss the

steps to be made to remediate the documentation gaps

Manager, Document Management Specialists January 2005 to November

2008

Bristol Myers Squibb, Information Management Princeton, NJ

Quality Assurance

Provided operational management in the creation of Global Shared Services

(GSS) business process documents, such as Policies, Standards, Directives,

and Procedures (SOPs, Work Instructions, and User Manuals) as defined in

the Quality System

. Managed the daily operation of the GSS procedural document management

system, including the development and maintenance of controlled documents

o Developed and maintained Document Management strategy and processes

for procedural documents to comply with BMS standards, including

periodic reviews and retention schedules

o Developed, implemented, and maintained document management system,

including document control, change control, and archiving

procedures

o Managed document creation, approval, revisions, distribution and

retention via EDMS (Documentum)

o Managed the annual reviews and revision of Standards, Directives,

Policies, and Procedures

o Managed the preparation, review and editing of technical documents,

including procedures and validation & SDLC records

o Reviewed and approved Document Change Requests (DCR) and Policies

and Procedures Request (PPR) for new documents

. Successfully implemented the documentation strategy across all GSS

locations, such as Mead Johnson IM, Financial Shared Services, Technical

Operations IM

. Worked with Records Management Task Teem to determine records retention

schedules for controlled documents

. Authored and edited procedural documents, validation documents and

internal communications.

. Reviewed and approved compliance procedures for the GSS Quality System

. Managed business relationship between the Document Management Group and

business partners

o Prepared and presented proposals for new business

o Assisted in the preparation of Time and Cost Estimates

o Facilitated meetings to discuss with potential DMG clients the BMS

procedural requirements and the DMG services

o Managed external relationships with Vendors

Successfully improved business processes and the quality of the team's work

. Performed quality review of team's work and track performance via monthly

metric

. Identified the cause of performance issues and successfully development

and implemented training programs and process changes

Managed a team of eight Document Management Specialists

. Created monthly performance metrics determine staffing needs and

opportunities for process improvement and costs reduction while improving

service.

. Designed and implemented a robust training program for DMG staff and

facilitate completion

. Developed e-training matrices which included assigning the appropriate

training to employees

. Established objectives for each direct report, perform mid-year and

annual performance evaluation and determine compensation packages

. Created job descriptions for the team roles and established a career

track for employees.

. Planned and managed documentation projects, including the collection,

distribution and archiving of documentation from cross-functional

disciplines and external partners

Worked with a cross functional team to implement organizational changes to

Document Management System and processes across BMS departments.

. Participated in a Kaizan event to harmonize business processes and

systems

. Worked with project team to implement documentation system

o Reviewed and contributed to the development of requirements.

o Reviewed and approved test plans and scripts for the implementation

of the DCM5 version of the Documentum document management system

o Performed IQ and UATs

o Participated in the development and approval of business

requirements, system design and testing strategy

o Participated in the development and execution of communication

plans

o Managed the development of training plan and materials

o Manage the reengineering of departmental business processes to

harmonize with other departments, included facilitating meetings

o Liaise with Mead Johnson, Financial Shared Services and Global

Logistics organizations to implement changes.

. Assisted with the development and implementation of both internal and

external communication and training materials

Member of the Audit Response Team

. Ensured that all required documents were available for auditors upon

request

. Maintained constant readiness for external regulatory audits

. Ensured that the required documents were available

. Respond to audit questions and provided the appropriate documentation to

answer audit questions

. Managed and executed process change strategies in response to audit

findings

Technical Writer/ Quality Assurance Manager (Consultant April 2002 - December

with RCM Technology) 2004

Bristol Myers Squibb, Global Shared Services Princeton, NJ

Assisted the Document Management project team in the creation of the Global

Shared Services Quality System and the formation of the Document Management

Group

. Worked with Document Management team to develop document management

strategies

. Developed departmental and Quality Systems Standard Operating Procedures

such as:

o Document approval and distribution process, Change control procedures,

Quality assurance guidelines and procedures, Audit SOP

. Wrote the Document Management Policy, Documentation Practices, and the

Numbering and Classification Standards, SDLC, System Validation and Audit

procedures

. Assisted in the implementation of the interim Documentum Docbase for

project documents

o Performed User Acceptance Test on the Documentum Docbase

o Defined folder levels and security requirements in Documentum

o Defined the roles and responsibilities for Docbase users

o Wrote the Documentum User Manual

. Created training materials for Technical Writers and Global Shared

Services management staff

Promoted to Quality Assurance Manager, 2003

Provided guidance to Technical Writers and BMS Departments in the creation

of procedural documents

. Developed Quality Assurance Review procedures and checklists for

procedural documents

. Performed quality Reviews of for procedural documents ensure that good

documentation practices

. Ensured that procedures were correctly documented and in compliance with

the Quality System, SDLC and/or Validation procedures

. Wrote Quality System Documents for the Document Management Group

o Reviewed and approved compliance procedures for Validations and Audits

before they were submitted to the Department Heads for signatures

. Collaborated with the Business Communication department and wrote the

communication materials for the role out of the GSS Quality System

materials.

Technical Writer (Consultant with Ciber Inc.) April 2001 - April

2002

Merck & Co., Inc. Whitehouse Station,

NJ

. Wrote System Development Life Cycle and Validation Documentation such as:

o Quality Assurance Plan

o Functional Requirements

o Design Specification

o Installation/Operational Qualification

o Test plans and Specifications

. Ensured that the appropriate documents were created for each phase of the

SDLC process

. Participated in Validation system testing

. Managed documents through the review, approval and distribution process

. Ensured that documents were created in Compliance with FDA regulations

. Wrote the system training manual

. Wrote the Data Repository Documentation including, Neutral Files, and

Metadata

Documentation Specialist (Consultant with Kelly Technical) May 2000 - April 2001

Ortho-Clinical Diagnostics Raritan, NJ

Managed the creation, maintenance, and revision of documentation pertaining

to research and development of Medical Devices and Assay and Reagents

utilizing the ISO 9001 Control of Quality Records, 21CFR Part 211, Current

Good Manufacturing Practices for Finished Pharmaceuticals, 21CFR Part 820,

Quality Systems Regulations

. Authored Design History and Device Master Records Documents

. Edited FDA regulated documents such as: Test Documents and Validation

Plans

. Ensured that technical documents followed the Standard Operating

Procedures

. Worked with product teams and Subject Matter Experts to expedite

revisions

. Authored departmental SOPs

Assisted in the compilation of documentation for regulatory submissions

Trained project team member on documentation practices

Managed the employees' training records

Business Procedures Consultant March 1999 - May 2000

Metropolitan Life Insurance Company Liberty Corner, NJ

Established and managed the Process Documentation function in the Business

Strategy Department of the Voluntary Benefit organization

. Developed the standard for documenting business processes

. Documented Voluntary Benefits Procedures and Processes

. Wrote and edited user manuals for Voluntary Benefits systems

. Created Marketing and Sales Materials for the roll out of the new Hyatt

Legal product

Worked for the Re-Engineering Team in the Voluntary Benefit Department to

assist in the development and documentation of new business processes

. Created "AS-IS" Process Maps to identify areas for improvement

. Reviewed existing documented procedures and streamlined to prevent

redundancies

. Worked closely with the end users, business subject matter experts, and

others to understand and help prioritize business goals and information

needs

. Assisted in the documentation of system requirements and design

specifications;

. Prepared status reports, and metrics for project manager and IT Project

Management

Procedure Analyst February 1998 - March

1999

Metropolitan Life Insurance Company Bridgewater, NJ

Product Leader for Group Universal Life

. Represented the Group Universal Life Department on the Reengineering

Team, to improve procedures

. Developed training materials and conducted training classes for Account

Representatives

. Created the Change Processing Manual and the Group Universal Life

Administrative Training Manual

. Created user guides and reference materials for new product

implementation - Hyatt

. Wrote the Y2K Business Continuity Plan for Voluntary Benefits

. Participated in the creation of Marketing Material such as Certificates

for Life Insurance

EDUCATION

Bachelor of Arts, Communication, The College of New Jersey, May 1987

Master of Science, Professional & Technical Communication, NJIT (In

progress)

Additional Training:

. Quality System & cGMP training, Ortho-Clinical Diagnostics, 2000

. 21 CFR Part 11 training, Bristol Myers Squibs, May, 2002

. GxP Awareness Training, NCS QA/CSV, Johnson & Johnson, Raritan, April

2004.

. Topics covered: World Regulatory Compliance and GxPs, Good Documentation

Practices, Regulatory Documentation (IQ/OQ, SOP/TOP, and CV) and Computer

Systems Validation. Preparation, Revision and Management of Standard

Operating Procedures, Installation Qualification / Operation

Qualification for Server Installations, Administration of Curriculum

Vitae, Global Regulatory Training Program

. Computer System Validation, NCS, Johnson & Johnson, September, 2004

. Complying with Computer and Software Validation Requirements, Institute

for International Research (IIR), November, 2007

. Introduction to Medical Writing, 2008[pic][pic]

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