Technical Writer Business Analyst
Resume:
ELLEN E. NEVINS
adxa4f@r.postjobfree.com
NJ or REMOTE Only
SUMMARY:
A Senior Business Analyst/Technical Writer with 20+ years’ experience in Pharma/CSV.
Twenty years’ experience with GxP and 21 CFR Part 11.
Sixteen years’ experience with GAMP4 (2001 – 2014) and GAMP5 (2015-2021).
Eight years’ experience with MHRA and Annex 11.
Five years’ experience in Clinical Systems, including LIMS.
Five years’ experience in Engineering/Networking organizations.
Three years’ experience with AWS.
Familiar with engineering and network concepts (WAN, switches, routers, firewalls, etc.)
Twenty years’ experience with VISIO.
Five years’ experience with HP QC / HP ALM.
Strong background in all phases of SDLC, software qualification and validation, GxP, and 21 CFR Part 11.
Highly skilled in the creation of user requirements, validation plans, summary reports and traceability matrices, prospective and retrospective IQs, OQs, and PQs, and gap analyses.
Twenty-five years’ experience in designing, developing, running, and evaluating unit, integration, system, and user acceptance tests.
Ability to quickly grasp complex technical concepts and express them in easily understood terms.
Excellent organization and communications skills.
Award-winning writer and published author.
Excellent collaboration skills.
Highly productive self-starter who works equally well independently or as part of a team.
Author of more than 250 validation documents, including validation plans, gap analyses, functional and technical specifications, RTMs, test plans, test cases, summary reports, SOPS, IQs, OQs, PQs, and Work Instructions for IT, Clinical, and Engineering (Network) processes..
Co-winner of NSPI Award for Outstanding Business Communications.
EDUCATION:
M.S. (Education/Language Arts), College of New Jersey, Trenton, NJ
B.S. (Education/Language Arts), Arcadia University, Glenside, PA
S.D.E.S. (Educational Psychology), Oxford University, Oxford, England
SKILLS:
21 CFR Parts 11 / 210 / 820, Access, Active Directory, Adobe Acrobat, Agile, ALCOA, Annex 11, AWS, Azure, BMC RemedyForce, Business Continuity, Captivate, Change Management, Compliance Wire, Confluence, CRM, CSV, Data Integrity, Disaster Recovery, Docspace, Documentum, Dynamics 365, EDMS, Excel, FirstDoc, FrameMaker, Front Page, GMP, GCP, GLP, HP ALM, HTML, IaaS, Interviewing, ISO, ITIL, IQ / OQ / PQ, Jenkins, Jira, LIMS, LMS, Maximo, Metadata, MS Dynamics CRM, MHRA, NIST, PaaS, Photoshop, PowerPoint, Qumas, Remedy, Risk Assessment, Runbook, SaaS, SalesForce, SAP ECC 6.0 (IM, WM), SDLC, ServiceNow, SharePoint, SnagIt, SOP, Testing, Test Plans, UAT, Validation, Veeva, VISIO, WI, Windows 7, Windows 10, Word.
TRAINING:
Data Integrity – BMS, 2020; Merck, 2020; Amarin 2021
FirstDoc - Merck, 2016
Dynamics 365, Ascensia, 2017
Docspace - Johnson & Johnson, 2015
JD Edwards - Zoetis, 2015
Veeva Vault - Zoetis, 2015; Janssen, 2022
HP / ALM – Zoetis, 2015; Merck 2016, Merck 2020
ICE – Novartis, 2014
SDLC – J&J ITS, 2012; Sanofi, 2014; Merck 2016; Amarin 2021
Good Documentation Practices - J&J ITS, 2011; Merck 2016, Merck 2020; Amarin 2021
AGILE - J&J, 2011; Merck, 2016; Janssen, 2022
CAPA - J&J ITS, 2011; Ascensia 2017
SAP 6.0 WM, DM - Johnson & Johnson, 2009, BMS 2010
HTML/Dreamweaver - RVCC, 2009
Project Management - Johnson & Johnson, 2003; Amarin 2021
Achieving and Maintaining 21CFR Part 11 Compliance - Validation Associates, 2002; Amarin 2021
Computer System Validation - Johnson & Johnson, 2002
Computer System Validation in Regulated Industries - Validation Associates, 2002
Electronic Records Management - Johnson & Johnson, 2003, 2011
Validation Basics - Taratec, 1995
Task Force Management - AT&T, 1987
Interviewing Techniques – AT&T, 1985
EXPERIENCE:
06/22 – 10/22
Janssen, Titusville, NJ (Remote)
Business Analyst/Technical Writer (Contractor)
Attended scrums and met with SMEs to gather requirements for an installation of AETION AEP on AWS.
Updated user stories in Jira.
Created the User Requirements Specification and Functional Design Specification, and updated as needed.
Circulated the URS, and reviewed and responded to feedback.
Created a Process Flow for system use.
Created a Work Instruction for system use.
03/22 – 05/22
Moderna, Boston, MA (Remote)
Technical Writer/Business Analyst (Contractor)
Met with SMEs to determine requirements for an addition to LabVantage LIMS processing on AWS.
Created seven Work Instructions to accompany an existing SOP for adding and processing batches in LabVantage LIMS.
Created sixteen UAT scripts for the LabVantage LIMS batch processing upgrade.
Tested the upgrade, and reported the results.
03/21 – 09/21
Amarin Pharmaceutics, Bridgewater, NJ
IT Compliance/ Validation Specialist (Contractor)
Managed an upgrade to an electronic document management system (ENSUR).
Created the Validation Plan, User Requirements Specification, Functional Design Specification, Migration Plan, and RTM for the upgrade, and managed the actual migration to AWS.
Identified gaps between required documentation and Amarin’s existing documentation.
Created Policy Documents and SOPs for the following: Back Ups and Restores, Business Continuity, Business Impact Assessment, Change Control, Risk Management, Data Integrity, Data Migration, Good Documentation Practices, Periodic Review, System Decommissioning, SDLC, Validation Master Plan.
Responded to internal audits on behalf of the IT Director.
07/20 – 12/20
Merck, MMD IT Global Quality, Whitehouse Station, NJ
Sr. Business /Validation Analyst (Contractor)
Interfaced with Infrastructure and Project Management staff to identify infrastructure requirements for a new company.
Identified and documented required documentation for each infrastructure occurrence in the new company.
Created validation protocols for the infrastructure components.
02/20 – 07/20
BMS, Quality Systems & Learning Management, Hopewell, NJ
Sr. Procedural Document Writer (Contractor)
Interfaced with Clinical Trial personnel to identify documentation needs and identify required content for LIMS and other clinical software.
Created Work Instructions and Job Aids based upon input received.
Updated existing documents to reflect current practices.
Managed the documents in QUMAS, and circulated documents for approvals and implementation.
02/19 – 02/20
Covanta, Morristown, NJ
Senior Business Analyst (Contactor)
Interfaced with Architecture and Infrastructure engineers to identify required Standards, SOPs, and Work Instructions for the Technical Operations and Security Department.
Created Standards, SOPS, WIs, VISIO flows, and templates for infrastructure components and processes.
Maintained a SharePoint repository for the documents, and circulated them for approval.
Attended meetings with upper management to remain abreast of architecture- and infrastructure-related changes to ensure that all documents were kept current.
10/18 – 02/19
Akorn, Somerset, NJ
Senior Business / Validation Analyst (Contractor)
Interfaced with QC Chem Lab Managers, Analysts, and QA Specialists to identify and remediate lab procedures for a laboratory move and installation of new instruments.
Created SOPs for the operation, calibration, maintenance, and administration of Chem Lab Instruments: FTIR, pH Meter, Heating Oven, Water Bath, Particle Analyzer, Oil Bath.
Updated SOPs on Laboratory processes: Managing hazardous materials; labeling and storing hazardous materials; managing stock stability, creating Logbooks and Analyst Notebooks, and others.
Created Learning Assessments for SOPs for delivery via Compliancewire.
01/18 – 08/18
Covance, Princeton, NJ
Lead Validation Analyst (Contractor)
Created a UAT Master Test Plan for an upgrade to Win 10.
Created detailed UAT scripts for the upgrade of critical applications.
Created Work Instructions for UAT testers and a basic user guide for Win 10.
Trained testers on the UAT process and documentation requirements.
Created process flows for test plans and use of Windows 10.
Worked with IT to facilitate interface access.
Managed UAT testing efforts and assisted testers as needed.
Tracked the test progress and results and reported same to upper management.
Managed the UAT documents in SharePoint.
Updated the HR applications in the Global System Inventory.
Created the Test Summary Report.
03/17 – 09/17
Ascensia, Parsippany, NJ
Lead Validation Analyst (Contractor)
Created a Validation Plan, Acceptance Test Plan, and Acceptance Test Summary Report for a LIMS system.
Created a UAT Test Plan and UAT scripts for MS Dynamics CRM.
Reviewed test runs for MS Dynamics CRM, and monitored and reported defects.
Managed the UAT documents in SharePoint.
01/17 – 03/17
PRA, Raleigh, NC
Senior Validation Analyst (Contractor)
Reviewed and corrected Validation documents (Validation Plans and Reports, Acceptance Plans and Reports, Test Scripts and Test Results, Change Requests and Closeout Documents) to ensure accuracy, completeness, and compliance.
Created a template for a Test Strategy Plan.
Created a PowerPoint Training document to train other Software Quality Engineers on the Quality Review process.
Researched validation benchmarks and timelines and compiled results for upper management.
03/16 – 09/16
Merck, Readington, NJ
Validation Lead (Contractor)
Created QAPs, DTPs, ATPs, DSRs, RTMs, and QASRs.
Reviewed and approved Installation, Unit, System, Performance, and UAT Test Scripts in HP / ALM.
Managed documents in FirstDoc, and circulated GxP documents for workgroup and QA approval.
Performed GxP and Risk Assessments to determine Validation requirements.
08/15 – 12/15
Johnson & Johnson, Bridgewater, NJ
Sr. Business / Validation Analyst (Contractor)
Met with system owners to identify and update documentation requirements.
Harmonized existing SOPs across MD&D Clinical Research Departments (Ethicon, DePuy, Acclarent, Biosense Webster).
Created new SOPs and WIs for various clinical research functions.
Created SOPs and WIs for data conversion and disaster recovery.
Created a test summary report for disaster recovery testing.
04/15 – 08/15
Zoetis, Florham Park, NJ
Validation Lead (Contractor)
Created guidelines and a template for conducting risk assessments in compliance with 21 CFR Parts 11, 201, 211, and 820.
Performed Risk Assessments and created Validation plans for APS and ZLIMS modules as part of a global Streamlink / SAP implementation.
Created OQ and PQ templates and documents.
Created a Global Validation Strategy template.
Created Validation Summary Reports.
Reviewed and approved Installation, Unit, System, Performance, and UAT Test Scripts in HP / ALM.
Reviewed and approved validation deliverables created by other members of the Compliance team.
Met with development team members to confirm requirements and review risk assessments and other deliverables.
10/14 – 12/14
SANOFI, Bridgewater, NJ
Business / Validation Technical Writer (Contractor)
Combined existing versions of business and technical requirements into a single current document.
Updated specifications for a GUI INIT portal.
Created, ran, and evaluated UATs on a beta version of the portal.
Documented test results and reported deviations to upper management.
05/14 – 09/14
GALAXE SOLUTIONS, Somerset, NJ
CSV Lead (Contractor)
Performed Risk Assessments and created Validation plans for upgrades to Windows 7 / IE 8 for CRS, Dental CRF, and Compliance Wire applications.
Reviewed and approved validation documents, including test plans, test scripts, and test summary reports.
Executed test scripts in HP / ALM and reported all defects.
Monitored defect resolution in HP / ALM and re-tested software as appropriate.
Managed two CSV analysts.
09/12 – 03/14
SONEPAR, Hamilton, NJ
Business Analyst/Technical Writer (Contractor)
Created SOPs, TOPs, and Process Flows for all Helpdesk Functions, e.g., creating accounts in Active Directory.
Created corporate directives for Business Impact Analyses, Disaster Recover Planning, and Business Continuity.
Created corporate policies, e.g., system security, backups and restores, and TOPs.
Reviewed SOPs, WIs, and other documents for compliance with internal guidelines.
Created Disaster Recovery Plans for Exchange and Networker.
10/11 – 09/12
J&J ITS, Raritan, NJ
Business / Validation Analyst Writer (Contractor)
Reviewed SOPs, WIs, and other documents for compliance with GxP and internal guidelines.
Uploaded documents into a Documentum-based EDMS (QUMAS).
Created Work Instructions for various aspects of EDMS management, e.g., updating bookmarks and reviewing and resolving annotations.
Trained users on EDMS.
Received training on required processes via ComplianceWire.
12/10 – 10/11
BMS, Plainsboro, NJ
Business Analyst / Technical Writer (Contractor)
Created sixteen SOPs on Production Planning, as well as WORD and Captivate quizzes for same.
Created 26 Power Point Training Presentations and Work Instructions for SAP transactions associated with the SOPS.
Tracked the creation and approval of all of the above in SharePoint.
11/10 – 12/10
PRIORITY SOLUTIONS, Swedesboro, NJ
Validation Analyst (Contractor)
Created five SOPs on Supply Chain/Warehouse Management for an interim warehouse management system.
09/10 – 11/10
CELGENE, Warren, NJ
Validation Analyst (Contractor)
Created and reviewed test plans, test sets, test cases, and test results in HP / QC.
Created validation plans and validation reports for multiple systems.
Reviewed validation test plans, test results, and validation reports created by others.
Created an SOP on Global Compliance.
07/10 – 08/10
PFIZER, Morris Plains, NJ
Business Analyst (Contractor)
Documented report requirements and created SQL queries to retrieve the required values from HP-QC.
Created data maps for reconciling Wyeth report data with Pfizer report data.
05/10 – 07/10
KAPLAN EDUNEERING, Princeton, NJ
Validation Analyst (Contractor)
Created User and Functional requirements for an upgrade to the Compliance Wire System.
Created a set of 21 Requirements Traceability Matrices for the system.
Analyzed and updated related test scripts to reflect revised requirements.
02/10 – 05/10
WARNER CHILCOTT, Rockaway, NJ
Validation Analyst (Contractor)
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.
11/09 – 01/10
J&J ITS, Raritan, NJ
Validation Analyst (Contractor)
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.
Received training on required processes via Compliance Wire.
06/09 – 09/09
J&J HCS, Piscataway, NJ
Validation Analyst (Contractor)
Drafted, edited, and revised 75 Functional Design specification documents for IM/WM modules in an SAP ECC 6.0 system.
Rewrote a Data Migration strategy document for the DM module.
Drafted, 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.
Received training on required processes via Compliance Wire.
10/08 – 11/08
AMCS, Bridgewater, NJ
Validation Engineer (Contractor)
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).
04/08 – 06/08
BMS, North Brunswick, NJ
Validation Analyst/Team Lead (Contractor)
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.
12/07 – 03/08
NOVARTIS, East Hanover, NJ
Quality Manager – OTC (Contractor)
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.
09/07 – 11/07
BIOMET, Parsippany NJ
Validation Analyst (Contractor)
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 Assessments, Validation Protocols, Software Change Control, Software Requirements Specifications, and 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.
05/07 – 09/07
DENDRITE, Totowa, NJ
Manager of Quality Assurance (Contractor)
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, and Summary Report).
02/07 – 03/07
ASPREVA, Basking Ridge, NJ
Validation Manager (Contractor)
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.
2005 - 2006
BRISTOL-MYERS SQUIBB/CONVATEC, Skillman, NJ
Business Analyst / Technical Writer (Contractor)
Reformatted and rewrote a total of 33 SOPs for the Medical Affairs Department, to ensure compliance with GxP, 21 CFR, ICH, EMEA, and other foreign and domestic regulatory requirements and also with BMS’ Policies and Procedures Initiative.
Interfaced with the CRAs to create SOPs, work instructions, and job aids documenting clinical trial requirements and practices.
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.
2005
JOHNSON & JOHNSON NETWORKING AND COMPUTING SERVICES, Raritan, NJ
Validation Analyst (Contractor
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.
2003 - 2005
SCHERING PLOUGH, Kenilworth, NJ
Validation Analyst/UAT Team Lead (Contractor)
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, workflows, 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.
2003
GENTA, Berkeley Heights, NJ
Validation Analyst (Contractor)
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.
2001 - 2003
JOHNSON & JOHNSON, ITS, Raritan, NJ
Validation Analyst (Contractor)
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.
1999 - 2000
PROCTER & GAMBLE, Newtown, PA
Validation Analyst (Contractor)
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.
1993 - 1999
JOHNSON & JOHNSON, New Brunswick, NJ
Validation Analyst/QA Specialist (Contractor)
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 Benefits Systems 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/Benefits System.
Created and documented specifications for a proposed HRS/Benefits System.
Prepared test cases and test data for an Employee Self-Service System.
Created user documentation and training materials for the Service History Module.
ADDITIONAL EXPERIENCE:
COBOL Programmer
Data Systems Supervisor
Systems Analyst
Instructional Technologist
Course Developer
Trainer
Adjunct College Instructor (TCNJ)
Editor, Rand McNally
ADDITIONAL:
Member, "Who's Who in Professional and Executive Women," 1987 – 1992
NSPI Award for Excellence in Written Communications, 1986
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