SUMMARY OF SKILLS:

A Certified Senior Technical Writer with extensive experience in quality assurance, validation, and documentation. Highly skilled in the design, development, execution, and documentation of test plans, test cases, and test data, and in preparing summary reports and traceability matrices. Strong background in all phases of system development, software qualification and validation, and 21 CFR Part 11, including the preparation of SOPS, Validation Plans, IQs, OQs, and PQs, and performance of gap analyses and audits. Familiar with GxP and GAMP guidelines, and relevant sections of FDA code. Excellent organization and communications skills. (Published author.) Excellent collaboration skills. Self - starter who works equally well independently or as part of a team.

SELECTED WORK EXPERIENCE AND ACCOMPLISHMENTS:

As a Technical Writer / Validation Analyst,Confidential, ( ):

• Clarified and rewrote User and Functional requirements for an upgrade to the ComplianceWire System.
• Created a series of 21 Requirements Traceability Matrices for the system.

As a Technical Writer / Business Analyst, Confidential, ( ):

• Created a URS, FRS, validation plan, and validation summary report for an Electronic Document Submission system.
• Created SOPS on Document Migration, Change Control, System Security, and several other topics.
• Created templates for IQs, OQs, SOPs, User and Functional Requirements, and several other validation documents.

As a Technical Writer, Confidential, ( ):

• Created an overall compliance plan for the establishment of a new data center.
• Created qualification plans for 8 Operational Capability Tools (e.g., Net Backup, VMware).
• Performed a gap analysis to determine what approved templates were needed to install hardware and software in the data center.
• Created templates for prospective and retrospective IQs/OQs.
• Monitored the status of all compliance-related deliverables, and reported on same to management.

As a Technical Writer, Confidential, ( ):

• Drafted, edited, and / or revised 75 Functional Design specification documents for IM/WM modules in a SAP ECC 6.0 system
• Rewrote a Data Migration strategy document for the DM module
• Edited and revised 26 Business Process documents for the IM/WM modules
• Drafted new templates for the Business Process and Functional Design Specification documents.
• Created a job aid for using the new templates.

As Technical Writer / Validation Analyst, Confidential, ( ):

• Created an IQ, OQ, and PPQ for a Siemens Process Control System
• Created a PowerPoint training presentation on validation basics (21 CFR Parts 11 and 211).

As a Technical Writer, Confidential,( ):

• Created User and Functional requirements for a major system upgrade
• Created spreadsheets for tracking development and completion of validation deliverables
• Created the Requirements Traceability Matrix for the upgrade.

As a Technical Writer, Confidential,( ):

• Created an SOP for creating and managing a repository for hardcopies of qualification documents
• Created all related templates and forms
• Reviewed and approved validation documents created by infrastructure team members at remote locations across the country
• Populated a Lotus Notes Database with electronic copies of infrastructure-related validation documents
• Monitored status of database development, and reported to management on same.

As a Technical Writer Confidential, ( ):

• Completed a Gap Analysis of all existing validation documentation, identified all missing documentation, and created a documentation development plan using MS-Project
• Created and monitored CAPA reports regarding compliance issues, and reported to upper management on progress made to resolve open issues
• Created SOPs and related templates for Risk Assessment, Validation Protocols, Software Change Control, Software Requirements Specifications, Validation Summary Reports
• Created a Validation Master Plan, Validation Protocol, Validation Summary Report, and Software Change Control Procedure
• Created a Validation Master Plan for software validations at all Biomet facilities
• Created training materials, and delivered training on the new documents.

As Manager of Quality Assurance, Confidential, ( ):

• Conducted a Gap Analysis to identify all additional documentation required for compliance
• Created and monitored CAPA reports regarding compliance issues, and reported to upper management on progress made to resolve open issues
• Created SOPs on CAPA, Vendor and Internal Audits, Risk Analysis, and Change Control
• Created written and electronic versions of learning assessments for departmental SOPs
• Created Vendor Audit Plans and assessment tools for two vendor audits
• Developed guidelines for annual internal audits
• Created templates for validation documents (IQ, OQ, PQ, Validation Plan, Traceability Matrix, Summary Report).

As a Technical Writer / Validation Analyst Confidential,( ):

• Met with all levels of management to determine the appropriate validation strategy for migration of document storage to an ECM system
• Completed a validation plan for the system
• Completed the Gap Analysis and Risk Analysis, and formulated a remediation plan using MS-Project
• Identified all required documentation, including all required SOPS, and created templates for same
• Created a SOP for creating SOPs
• Created the User Requirements document and the corresponding Requirements Traceability Matrix.
• Created test scenarios and test scripts
• Created a template for a Validation Summary report

As a Technical Writer / Validation Analyst Confidential, ( ):

• Reformatted and rewrote a total of 33 SOPs for the Medical Affairs Department, to ensure compliance with GCP, 21 CFR, and foreign and domestic regulatory requirements and also with BMS’ Policies and Procedures Initiative.
• Entered and tracked status of CAPA issues
• Created Work Instructions for using RAPID, the Document Management System
• Created a SOP and work instructions for Sample Manager LIMS Account and Security Administration
• Created a complete set of SOPS and several sets of work instructions for using MAXIMO
• Created test cases and Requirements Traceability documents for a CRM System

As a Technical Writer / Validation Analyst Confidential, ( ):

• Reviewed validation / compliance requirements for SOX and GxP servers with site managers
• Conducted a CSV audit and prepared a position paper for ensuring compliance for all SOX and GxP servers and applications being migrated to one of three central locations as part of a data center consolidation, and presented findings to all levels of management
• Using Documentum, tracked progress of server and application moves, and submission and approval of all relevant documentation
• Met daily with department managers, project manager, and Director of QA to ensure ongoing compliance with SOX, GxP, and all other applicable regulatory requirements.

As a Technical Writer / Validation Analyst Confidential, ( 005):

• Created system specifications for a LIMS (QAS)
• Completed the Risk Analysis and Gap (CSV) Analysis for the system, and formulated a remediation plan
• Identified system test cases and developed test scripts for three validated legacy systems, including a calibration system (Documints) and a LIMS (QAS)
• Ran test scripts and documented results
• Worked with LIMS users to develop user acceptance tests
• Trained users on testing procedures, and managed execution of user acceptance tests
• Created exception reports, summary reports, requirements traceability matrices, directories, and related documents
• Developed SOPs, IQs/OQs/PQs, user manuals, work flows, data flows, and a training manual as part of the qualification and validation efforts
• Interfaced with Business Owners and departmental Quality Assurance organization to ensure that all documents satisfied GxP and FDA requirements.

As a Validation Analyst Confidential, ( ):

• Conducted a CSV audit to determine what documentation was required, and prepared a remediation plan for developing same
• Developed and maintained SOPs on disaster recovery, emergency planning, system security, and change control.
• Ran validation tests, evaluated test results, and prepared exception reports for an adverse reaction reporting system
• Developed system checklists and job aids, and a company IT Manual as part of the qualification and validation efforts
• Interfaced with departmental Quality Assurance organization to ensure that all documents satisfied FDA requirements.

As a Technical Writer / Validation Analyst Confidential, ( ):

• Created and maintained the IQ/OQ templates used to document the installation and operation of qualified and validated Windows, Unix, and Linux systems, and trained system engineers on the use of the templates
• Created and maintained the IQ/OQ templates used to document the migration of servers from NT to Windows 2000, and tracked the migration activities
• Reviewed all completed IQs/OQs, checklists, and other documents for accuracy and compliance with GxP and FDA rules and regulations
• Created guidelines and procedures for ensuring compliance
• Created and maintained SOPS, TOPS (Work Instructions), checklists, job aids, and other documents that were used as part of the qualification and validation efforts
• Interfaced with departmental Quality Assurance organization to ensure that all documents satisfied FDA requirements
• Created and implemented a departmental website that provided access to the above-mentioned documentation
• Arranged and supervised initial and on-going qualification and validation training for an infrastructure support team comprised of 24 system engineers
• Created and delivered a training course on 21 CFR Part 11
• Scheduled and monitored compliance and validation training for all engineers
• Tracked the progress of all qualification and validation activities for the support team
• Attended training as needed to reinforce knowledge of qualification and validation regulations and remain current on same.

As a Technical Writer / Validation Analyst Confidential,( ):

• Interfaced with system managers and users to conduct a Gap Analysis and determine system and documentation needs
• Created a remediation plan to address these needs
• Designed and developed user documentation and job aids for a Marketing Management System
• Created test scripts, developed test cases and test case data, and ran system and user acceptance tests
• Documented and evaluated test results, and recommended system modifications based upon same
• Created training materials for new system users.

As a Validation Analyst Confidential,( 9):

• Tested and validated a Training Administration Management System for compliance with FDA regulations
• Conducted a Gap Analysis of the system, and prepared the remediation plan
• Created all documentation required by the remediation plan
• Tested and documented an HRS/Personnel System
• Tested a Personnel and Benef Confidential s for Y2K compliance
• Tested a Training Administration System, a Blood Drive Administration System, and a revised Service History Module
• Developed and documented all test protocols, test plans, test cases, and test data for each of the above
• Documented test results and recommended system changes based on same
• Documented the functionality of an existing HRS/Benef Confidential
• Created and documented specifications for a proposed HRS/Benef Confidential
• Prepared test cases and test data for an Employee Self-Service System
• Created user documentation and training materials for the Service History Module.

Earlier work experience:

• COBOL programmer
• Data Systems Supervisor
• Systems analyst
• Instructional technologist
• Course developer
• Trainer

GENERIC SOFTWARE PACKAGES:

Access, Adobe Acrobat, COBOL, Dreamweaver, Documentum, elementK, Excel, Framemaker, Front Page, HTML, LIMS, Photoshop, Powerpoint, ProTerm, RAPID, Replay, SAP ECC 6.0 (IM, WM), Sharepoint, SnagIt, SQL, Trackwise, Unix, VISIO, webMethods, Windows 2000, Windows XP, Word, Word Perfect.