Software Development Life Cycle
Resume:
JEFFREY ROBERTS
ad5rql@r.postjobfree.com
https://www.validation-consultants.com
TECHNICAL SKILLS
• Computer Software Assurance (CSA) • Computer System Validation (CSV)
• Corrective Action Preventative Action (CAPA) • Design History File (DHF)
• FDA 21 CFR Part 11, Part 820 • Good X Practices (GXP)
• Installation Qualification (IQ) • ISO-13485
• LabLynx LIMS • LabWare LIMS
• Operation Qualification (OQ) • Performance Qualification (PQ)
• Regression Testing • Software Development Life Cycle (SDLC)
• Standard Operation Procedure (SOP) • Structured Query Language (SQL) EQUIPMENT
• Alere Triage Immunoassay Meter • Alere Triage Meter Pro Immunoassay
• Capture Immunoassay Workstation • CDAS (Chromatography Data Acquisition Stm)
• CSAT Label Printer • C-350/C-370 Low Speed Saw/High Speed Saw
• Echo Immunoassay Workstation • FADAL 4020 Tooling Machine System
• IMM (Injection Molding Machine) • Immuspin Centrifuge
• Natoli Tooling Pill Press • NEO Immunoassay Workstation
• PS2 Incubator • Pucker Machine
• TAM (Tokyo Automatic Machine) • Vial Capper, Vial Feeder, Vial Filler EDUCATION
University Alabama - BA Psychology/English
EXPERIENCE
04/19 to Now Validation Consultants (Senior Validation Engineer) Provide Computer System Validation (CSV) and Computer Software Assurance (CSA) services using the “V” model to ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR Part 820 and ISO-13485 to the following clients: Ø BioTelemetry (Philips) – validated NOVUS Inventory Order Management System (NIOP). Ø Brooks Life Sciences (BLS) – validated 14 different scanner machines. Ø Drug Plastics & Glass (DPG) - validated In Line Equipment Testing System. Ø Gaia Herbs – validated Paylocity Learning Management System (LMS). Ø Hemanext – validated DocuSign eSignature System. Ø J. M. Huber – validated Daily Oracle Functions System and Hand Held Scanner System. Ø Japan Tobacco International (JTI) – validated Manufacturing Execution System (MES) and Warehouse Management System (WMS).
Ø Taiho Oncology (TOI) – validated Track & Trace system and Pinnacle 21 Enterprise system. Write/execute the following Software Development Life Cycle (SDLC) documents: Ø Validation Master Plan (VMP)
Ø Functional Requirement Specifications (FRS)
Ø System Design Specifications (SDS)
Ø Installation Qualification (IQ)
Ø Operational Qualification (OQ)
Ø Performance Qualification (PQ)
Ø Requirements Trace Matrix (RTM)
Ø Validation Summary Report (VSR)
10/18 to 03/19 OFNI Systems (Senior QA/Validation Analyst) Provided CSA and CSV expertise for the systems used by the following client companies: Ø Bioinformatics – PEAKS Online is a mass spectrometry data analysis system. Ø Duke Health Technology Services – Provided validation for the Data Center. Ø LumaCyte – Illuminate is a laser force cytology suite that controls laser force cytology instruments. Ø Melinta – SharePoint Microsoft Office web based document management/storage system platform. Worked with IT and Quality groups to write the following Software Development Life Cycle (SDLC) documents: Validation Master Plan (VMP) Functional Requirement Specification
(FRS)
System Design Specifications
(SDS)
Installation Qualification (IQ),
Operational Qualification (OQ),
Performance Qualification (PQ)
Requirement Trace Matrix (RTM) Validation Summary Report
(VSR)
5/18 to 10/18 Johnson & Johnson Vision (Senior Validation Analyst) Used Process & Instrument Diagrams (P&ID) to create/manage the software validation/infrastructure qualification for the following SDLC documents to verify compliance with 21 CFR-820 and ISO-13485 for two new Tokyo Automatic Machines (TAM) contact lens Injection Molding Machines (IMM) added to an existing production line:
- Corrective/Preventative Action (CAPA) SOP - Design Failure Mode/Effect Analysis (DFMEA)
- Detailed Design Specification (DDS) - Functional Design Specification (FDS)
- IQ, OQ, PQ Test Plans - Quality Management System (QMS) SOP
- Requirements Trace Matrix (RTM) - Validation Summary Report (VSR) 12/17 to 3/18 Spinal Elements (Senior Software Validation Analyst) Managed the review/updating of the following Design History File (DHF) SDLC documents for the medical devices produced and used in cervical, thoracic and lumbar spinal surgical procedures to verify compliance with QMS, GxP, CFR 21-Part 11, CFR 21-Part 820 and ISO-13485:
- Risk Management Report - Risk Management Plan - Bill Of Materials (BOM)
- dFMEA - Design Input/Output Validation (DIOVV) - Device Master Record (DMR)
- Surgical Technique Guide (STG) - Instructions For Use (IFU) - Regression Test Plan 7/17 to 11/17 CryoLife (Senior Software Quality Engineer) Managed the review of all new IT Change Request forms and management of the IT Change Request Database. Managed all software validation for the following projects in compliance with GxP standards and ISO-13485:
- Electronic Data Interface (EDI)/GHX Database - IT Change Request Database - Unpacking Tissue Database 2/17 to 6/17 Alere (Validation Verification Analyst) Executed the IQ/OQ/PQ Test Plan for the Alere Triage Meter and Alere Triage Meter Pro immunoassay diagnostic testing hardware devices to prove compliance with CFR 21-Part 11, CFR 21-Part 820, ISO-13485 and GxP regulations. Wrote the Validation Summary Test report of test findings and results for both devices. Reviewed/updated the following Design History File (DHF) documents for twelve different software releases from 2001-2010 that provide data for diagnostic tests for infectious diseases, cardiometabolic diseases and toxicology:
- Software Development - Software Design Change - Risk Management - Regulatory
- Software Verification - Design Validation - Product Release - Requirements Trace Matrix 10/16 to 2/17 Zimmer Biomet (Senior Verification Validation Analyst) Managed the review/updating of the following Design History File (DHF) documents for the Knee, Hip and Elbow replacement product lines to verify compliance with CFR 21-Part 11/Part 820, ISO-13485 and GxP regulations:
- User Requirement Specification (URS) - Requirements Trace Matrix (RTM) - Installation Qualification (IQ)
- Operational Qualification (OQ) - Performance Qualification (PQ) - Validation Summary Report (VSR) 9/15 to 10/16 Philips Healthcare (Senior Validation Analyst) Provided validation for the following product/systems used by Philips Healthcare/Medical Devices group:
- Business To Business (B2B) Service Cloud - Service Max - One EMS - Quality Management System
- Systems, Applications, Products (SAP) - Excellence Through Quality (ETQ)
- QuickConnectivity Customer Service Portal - OmniChannel Customer Service Portal Provide/manage all in Sprint validation SDLC documentation compliance/performance reviews for the following documents per product (in conformance with CFR 21-Part 11, CFR 21-Part 820, ISO-13485 and GxP regulations) created by IT, Quality and Manufacturing teams using Agile methodology:
- Design Specification (DS) - Functional Requirement Specification (FRS) - Installation Qualification (IQ)
- Operational Qualification (OQ) - Performance Qualification (PQ) - User Requirement Spec (URS) 1/15 to 6/15 Halyard (Senior Validation/QA Analyst) Managed updating External Audit files for 2013, 2014 and 2015 to prepare (pre-auditing) for an upcoming FDA Audit to verify compliance with CFR 21-Part 11, CFR 21-Part 820, ISO-13485 and GxP regulations. Wrote User Requirements, Test Plan and Reference User Guide for the Audit Tracking Tool. Tested changes made to the Audit Tracking Tool and provided Validation Findings Summary Report. 6/14 to 12/14 GlaxoSmithKline (GSK) (Senior QA/Validation Analyst) Wrote the User Requirement Specification (URS) and Installation Qualification/Operational Qualification (IQ/OQ) documents for the Vial Filler, Vial Elevator, Feeder, Pucker and the Vial Capper systems for the Active Pharmaceutical Ingredient (API) production Line 75 to produce/package Nicotine Mini Lozenges at the GSK facility in Aiken, SC. Responsible for execution of IQ/OQ, FAT, SAT documents, Error Tracking and writing of the Validation Summary Reports.
6/13 to 2/14 DePuy Synthes (Johnson & Johnson) (Senior Validation Analyst) Assigned to the CAPA project to update/revise documents used in the Work Inspection Process for products created by the company. The company manufactures instruments, implants and biological materials used for the surgical correction and regeneration of the human skeleton/soft tissues. Responsible for updating Work Instructions and Standard Operating Procedure (SOP) documents for users in the USA and European Union. 7/12 to 1/13 Terumo (Validation/QA Specialist)
Worked with end users and managers to write Intended Usage, Validation Plan, Functional Requirements, System Configuration Specification, Installation Qualification (IQ), Operation Qualification (OQ), Trace Matrix and Validation Summary Report documents used to validate the FADAL 4020 Tooling Machine System, C-350 A/NC High Speed Saw and C-370 A/NC Low Speed Saw used to create parts for heart/lung machines. 2/11 to 10/11 Immucor (Senior QA/Validation Specialist) Wrote the Requirement, Design Specification, IQ, OQ, PQ and Traceability documents for Arkonet Version 1.5 & Version 1.6. Arkonet Version 1.5/1.6 is a software package that stores blood assay results and allows users to view, modify and validate results through usage of an Internet Browser. Validated Hematology Hardware for Echo, NEO and Capture Workstation (P2 Incubator, CSW100 Automated Washer, Immuspin Centrifuge). Verified compliance to GMP SOP’s, SDLC, 21 CFR-Part 11, 21 CFR-Part 820, ISO-13485 and GxP regulations. 9/10 to 12/10 CIBA Vision (Senior Validation Tester/Auditor) Wrote PQ documents that provided testing for twenty TrackWise Crystal Performance Indicator (KPI) Reports used by CIBA Management. Managed execution of PQ documents used by local and remote end users. Provided Change Control, Error Tracking/Error Resolution for all errors found during PQ execution. Wrote/updated Traceability Matrix documents for TrackWise Crystal Reports to show traceability from Requirement to Specification to IQ/OQ/PQ. Responsible for auditing 8 company manufacturing/distribution sites to verify compliance with corporate GMP SOP documents and reporting of audit findings in a report. 2/10 to 6/10 LABLynx (LIMS) (Validation/QA/Auditor) Provided an on-site audit (pre-auditing) and External Audit Findings Report of LabLynx corporate site and two Data Centers for compliance with 21 CFR-Part 11 and GxP regulations. Created eight SOP documents used within LabLynx (LIMS). Wrote the following documents for LABLynx Elab LIMS product installed at Bayer Healthcare:
- CAPA - IQ/OQ/PQ - Requirements - Specifications
- System Design - Traceability Matrix - Validation Master Plan - Validation Summary Report 11/09 to 2/10 VISTAKON (Johnson & Johnson) (Senior QA Tester) Responsible for writing the Requirements, System Specification, Test Plan and Trace Matrix documents for the Statistical Analysis Software (SAS) Web Data Analysis Tool. The SAS Web Data Analysis Tool allows users to create Bar Chart, Box Plot, Control Chart, Histogram, Probability Plot and Summary Statistics data reports. 10/08 to 1/09 C.R. Bard (QA/Validation Manager)
Wrote the Software Validation Department Standard Operating Procedure (SOP) document for use within the QA group to verify compliance with 21 CFR-Part 11, 21 CFR -Part 820 and GxP regulations. Wrote the following documents that trace to the Software Validation Department SOP:
- 21 CFR Part 11 Assessment - Validation Master Plan - Requirement Specification -SOP
- Test Plan - Test Scripts - Traceability Matrix - Validation Summary Report 1/08 to 10/08 Beaufort Advisors (Lead Auditor/Project Manager) Provided on-site External Auditing services for 21 CFR-Part 11 & GxP Compliance Audits and Quality Management Audits for companies utilizing Electronic Data Capture (EDC) and Interactive Voice Response Systems (IVRS). Responsible for conducting the audits and writing the Audit Summary Report of findings. Managed a staff of four employees. Audited /wrote Audit Summary Findings Report for the following client sites:
- Case Western University (REDIARC - DataTek - Total Systems Services (TSYS)
- General Electric – Health Care (GEHC) - Research Pharm Services (RPS) - United BioSource (UBS) 10/06 to 12/07 Atlantic Scale (Senior QA/Validation Manager) Wrote/executed IQ, OQ and PQ documents for Gage InSite. Gage InSite is a 21 CFR-Part 11 compliant gage equipment/calibration management software application used by calibration labs. Wrote Requirements, Specifications, Validation Plan, SOP, and Trace Matrix documents. 10/05 to 9/06 Leiner Health Products (Senior QA Tester) Wrote and executed IQ, OQ and PQ Test Plans for an Active Pharmaceutical Ingredient (API) project to provide validation for:
- CSAT Label Printer - Distribution System Server - Natoli Tooling Pill Press System Responsible for documentation and tracking of all testing errors. Provided Powerpoint system flowcharts. Worked with developers, testers and analysts to resolve all issues. 11/04 to 10/05 Wyeth Pharmaceuticals (LIMS Validation Specialist) Executed Test Plans/Test Scripts for Site Configurable Objects (SCO) to verify changes to LabWare LIMS (Version 5.0)/LACES. Documented and tracked all errors found during test execution in Development environment and QA environment. Verified that all Test Cases trace back to a Requirement and Specification. 7/04 – 11/04 Philip Morris, USA (LIMS Business Analyst) Responsible for writing Test Cases for LabWare LIMS for Windows V 5.0 for the Product Testing Laboratory (PTL) Group. Used Microsoft Excel Test Case Template to write Test Cases for the Admin, Plenum and Ignition Propensity functions within LIMS. Verified that all Test Cases trace back to a Requirement Number as part of a Traceability Matrix document. Provided Unit Acceptance Testing, Regression Testing and Error Tracking support. 11/03 – 6/04 Schering-Plough (SPRI) (Senior Quality Reviewer) Reviewed the following department documents for multiple ongoing projects to insure compliance with established company document format templates, FDA 21 CFR – Part 11 & GxP guidelines:
- Installation Qualification (IQ) - Operational Qualification (OQ) - Performance Qualification (PQ) 6/03 – 11/03 Wyeth Pharmaceuticals (LIMS Validation Test Analyst) Performed execution of Performance Qualification (PQ) Test Scripts on LIMS (Version 5.0) in compliance with 21 CFR – Part 11 & GxP guidelines. Responsible for management of Error Tracking System using Microsoft Access Database. Provided updates/revisions to PQ Test Scripts based on errors found during PQ execution. 8/02-5/03 Schering-Plough (SPRI) (Senior Validation Specialist) Responsible for writing Performance Qualification (PQ) Unit Acceptance Test (UAT) Plan for LIMS V 4.03 using 21 CFR – Part 11 and GxP guidelines. Executed PQ/UAT Test Plan, documented/resolved all errors found and wrote PQ/UAT Test Summary Report. Created Requirement Trace Matrix (RTM) to provide traceability from the Requirements Document to the System Design Specification (SDS) document to the Test Script. 2/02-7/02 Aventis Pharmaceuticals (Validation Test Analyst) Used Interview Assessment Question List to determine if a system complies with 21 CFR - Part 11 & GxP regulations. Wrote Test Plan documents for the Medical Publications Review & Approval System, Medical Publications Database System and the Key Performance Indicators System to show regulation compliance. 9/01-2/02 Pharmacia (Validation Specialist)
Responsible for ensuring that all documentation/procedures comply with the 21 CFR - Part 11 & GxP guidelines. Worked with users, business analysts and managers to develop maintain validation procedures and Gap Analysis documents. Wrote/updated Requirements, Specifications, Installation Qualification (IQ), Operational Qualification
(OQ), Performance Qualification (PQ), Standard Operating Procedure (SOP). REFERENCES
Contact Name Company Name Phone Number Email
1. Peter Ackerman Advanced Medical
Consortium
978-***-**** peter.ackerman@
advancedmedicalsconsortium.com
2. Brian Coleman EAS Consulting 804-***-**** ad5rql@r.postjobfree.com 3. John Jones LabLynx 770-***-**** ad5rql@r.postjobfree.com 4. Frank Maddox Independent Consultant 678-***-**** ad5rql@r.postjobfree.com 5. Ed Roach GxPartners Group 317-***-**** ad5rql@r.postjobfree.com
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