PROFESSIONAL SUMMARY:

Senior Independent Quality & Compliance Specialist - Lead fulfills both quality assurance and quality control responsibilities for the applications. Solid dedication to Pharma, Biotech, Animal Health, Medical Device, and Healthcare firms; comprehensive focus on new product developments and projects, promoting high quality standards to deliverables, and ensuring clients satisfaction to completion. Strategic oversight, ultimately driving the success of global projects through project management, compliance & quality management, GxP regulated IT application/systems, regulatory, computer system validation and risk management, document control, technical writing, and user training combination of 26 plus years of resilient self-driven abilities.

KEY COMPETENCY:

• 21 CFR 11/EU GMP Annex 11 GAMP 5 standards
• Data Integrity
• Good manufacturing practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements
• Project management practices and techniques
• Software development life cycle
• Computer hardware and software applications including Quality related computer systems, MS Office and MS Project
• Principles and practices of computer compliance, validation, and qualification
• Knowledge of automated testing practices and tools (i.e. Intelligent Automation Robot)
• External and internal inspections
• Stakeholder management in a cross-functional organization
• Reviewing and Approving user, functional and design specifications
• Reviewing and Approving protocols and pre/post test scripts
• Sampling, testing, and measuring techniques
• Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution
• Selecting, training, supervising, and evaluating departmental personnel
• Managing multiple projects, duties, and tasks
• Communicating clearly and concisely, both orally and in writing
• Establishing and maintaining effective working relationship with those contacted during work
• Working remotely and effectively

TECHNICAL EXPERTISE:

Information Technology (IT) Microsoft Office Products Microsoft Office Professionals (Visio, Microsoft Project, Word, Excel, PowerPoint, etc.) Microsoft Access Engineering File Management System (EFMS) EE Work Manager McLaren AutoCAD Adobe Acrobat Appligent - Appendo Pro Development builds Servers Schema Stored procedures Snag-It UNIX VAX/VMS Crystal Reports Visual Source Safe (VSS) Seapine PVCS Tracking System eClinical JIRA SharePoint Training NextDocs Multi-tier Internet applications Net technologies Oracle Clinical Dream Writer Internet/Intranet Documentum 7.0 Disk Operating System (DOS) Management System Eroom HTML/XML & Databases SQL Arbor text Authoring Networking/Window Security Databases/Validation or Test Environments Cloud migration Desk Top Publishing applications Manual/Automated Testing Rational Requisite Pro Mercury Suite Web Applications SaaS Cloud Based Windows Processors Web Services and Databases Report Manager WebEx Training Document Control Manuscript DocuSphere TransPerfect(Language Translation)Trial Interactive System Minitab AWS Active Directory ITIL VMWare LAN JDEEnterprise One (OneWorld, XE) Lab Instruments MasterControl Quality Center EFMS SAS/SQL Institute ) Lab Systems (Empower 3, Chromatography Data Acquisitions Systems (CDAS, LabX, DW, DSC, Open Lab etc.) 3rd Party Vendors CRO (PAREXEL) Enterprise Resource Planning (ERP) Data Migration ETL Veeva iConnect Gemini - XCP Graphnet eTMF BOT (Intelligent Automation Robotic) Veeva DOCIT Infinity, continuous knowledge maintained.

PROFESSIONAL EXPERIENCE:

Confidential

Medical Writer

Responsibilities:

• responsible for drafting, formatting, and proofreading technical and scientific documentation, as well as working closely with both internal and external teams.
• Ensure documentation (e.g. proposals, imaging charters, final reports, and other scientific/technical documents) are prepared in a collaborative manner with both internal and customer cross-functional teams to meet the rigorous requirements of a regulated industry.
• Similarly, responsible for the preparation of additional documentation (e.g. technical reports, marketing material, work instructions, standard operating procedures) as needed.

Confidential

Technical Quality (TQ) Computer System Validation Lead

Responsibilities:

• Ensuring quality and compliance, CSV processes, testing, 21 part 11, and data integrity best practices will be adhered to.
• Accountable for multi-tasks GxP deliverables. Process pre-review of new test scripts in the Test Plans to confirm test documentation is align per test objective requirements and CSV/GxP processes and Approve/Close test scripts prior to test execution. Process post-review of test scripts execution in the Test Labs to confirm the test objective meet with test outcome requirement and CSV/GxP processes. Perform verification of defects to ensure logged per processes and linked correctly to the fail step prior to executing approval/closure of executed scripts.
• Overall maintain continuous communication with Technical and/or business owners via email or Team meetings. Scheduled one-on-one meetings with Technical and/or validation/business owners to communicate and mitigate discrepancies and/or defects to ensure accuracy and completion per requirements, CSV Risk Assessment, and GxP processes are followed. Managed and ensured the review and approval phase life cycle process via ensuring the test lab rejection and/or defect status is set to rework or re-execution, or approval/closure.
• Communicated via email daily status to the team on when pre/post test scripts are approved or rejected.
• Provided guidance to the business on the approval process for pre/post test scripts and defects.
• Trained testers/teams on Testing and HP ALM Best Practices, as well as business compliance processes.
• Attended weekly meetings with the cross functional/offshore teams on status of the script/test execution deliverables.
• Supported teams with reviewing and updating SDLC CSV process deliverables per business Processes, GxP implementations, and GAMP 5 guidelines Annex 11.
• Maintain training on business SOPs.

Confidential

Compliance Specialist Consultant, GxP IT Quality Assurance & eCompliance

Responsibilities:

• Managed and coordinated activities related to current
• Good Manufacturing Practice Enterprise Electronic Systems and Quality Reviewer/Approver.
• Duties included leading, developing, and maintaining compliance activities across Information Technology Enterprise Services supporting regulated Information Technology areas applications.
• Responsible for developing policies and procedures and coordinating all activities relevant between the Quality department, Information Technology validation and Information Technology in relation to implementation, maintenance, and change control of computerized systems.
• Providing quality/compliance oversight to all computer system validation related activities across the GPS Enterprise. Guiding the staff to ensure a comprehensive System Development Lifecycle Methodology in alignment with GAMP 5 requirements. Providing support services and governance to all supporting IT areas (GPS corporate and sites) to ensure global alignment to computer compliance, global validation and change control standards. Providing Support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned. Evaluate and administer consultation on computer validation issues related to Quality related computer systems; worked closely with Information Technology and Quality Operations on theses related issues.
• Ensured enterprise level metrics and tracking for Corporate Computer related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control. Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards. Performs related duties as assigned qualifications.

Confidential

Senior Quality Liaison Lead & Technical Writer

Responsibilities:

• Managed quality systems procedures for the new 3D printer installation at the manufacturing site.
• Technical writing Lead for several technical/quality engineers writing SOPs (e.g. Work Instruction, Training, and forms documents).
• Reviewed and ensured the quality systems documentation are compliant and meeting business requirements, as well as GxP and ISO 13485 standards.
• Maintained and tracked all activities progress in various applications and make suggestions on process to mitigate any non-conformance or CAPA actions through meetings and daily activities.
• Prepared and routed documentation for global sites translations, training, and approvals.
• Supplier Liaison for ensuring suppliers selected deliverables are completed, reviewed, and approved prior to onboarding; provided weekly updates on project deliverables status.
• Performed various CSV activities (e.g. provided compliance comments to engineers on process validation documentation).

Confidential

Senior Quality and Computer Validation Lead &Technical Writer

Responsibilities:

• Lead and managed Clinical project development plans for the proposed data flow and processes of the Digital Research Network Software (DRN) for Clinical Trials.
• Supported Regulatory Associates (RA) and Clinical Data Managers (CDM) on implementing the Electronic Data Management (EDM) systems.
• Drafted and managed the outline of the Quality Management System (QMS) document deliverables (Gamp 5, CSV, and GCP) for approvals via interviewing SMEs for detailed content, review edits, and finalize changes in a timely manner.
• Ensured FDA, Good Clinical Practice (GCP), and Global Drug and Device, Biologics Development Regulations are adhered to with drafting the documentation, as well as supported documentation during audits.

Confidential

Director of Quality & Compliance, IT

Responsibilities:

• Oversee and lead project workstreams for CSV GxP/non-GxP quality/compliant infrastructures and various applications implementations, new systems, infrastructure qualifications, quality management systems as such, eQMS, EtQ, Complaints, Master Control, data migrations, remediations, etc.
• Performed Quality review and approval of procedures.
• Drive workstream leads to ensure GxP and non GxP deliverables (SDLC/GAMP 5/CSV) are met according the verification and validation SOP, as well as complied with FDA, GxP regulations and GAMP 5 standards.
• Traveled to sites formed governance with the quality and IT compliance team in Inverness, Scotland collaborating on strategies to ensure consistency across all functions.
• Make suggestions and recommendations to workstreams on their project deliverables, approach strategies, and SDLC processes.
• Took ownership of and accountability for, as well as successfully ensure approximately 40+ workstream leads and their teams (offshore teams, procurement vendors, contractors) were trained on SOPs and GxP processes to maintain compliant in GxP within 2-3 weeks prior to execution phases begin.
• Joined daily project meetings to ensure the quality and compliance is being adhered to.
• Address project related problems and suggest resolutions using CAPA process.
• Support onboarding specialist with implementing the appropriate process for ensuring members have consistent information on the project as well as in corporate into the related team per job responsibilities. Trained workstreams on the processes and procedures to ensure compliance.
• Lead vendor selections for validation support on infrastructure and application installations/implementations.
• Overall driven flawless execution of services and continuous improvement facilitate communication and coordination efforts with Business Partners, IT SalesForce.com Business Analyst, and other IT support teams.
• Ensured regulated automated tools used in the Quality System are appropriately validated and controlled through their life cycle from development, deployment, change control and retirement.
• Ensured project teams adhere to processes and control mechanisms for software, hardware, data, and relevant security to meet regulatory requirements.

Confidential

Director of Quality and Compliance & IT Administrator

Responsibilities:

• As needed, support quality and compliance services on tasks related to medical marijuana.
• As the admin, provide support to the teams on SharePoint, grant access and establish permissions to specific departmental library folders as well as software and hardware support.
• Assist with creating excel spreadsheets for marketing.

Confidential, Chicago IL

Regulatory Specialist

Responsibilities:

• Provided various regulatory support, e.g. marketing of products, 510k submissions) to clients on needed basis for Confidential .

Confidential

Quality & Compliance/ Senior Technical Writer Lead/PM

Responsibilities:

• Performed CSV and technical writing for Laboratory Systems at pharma/biotech & International company via remote. Collaborated with QC laboratory (Lab) teams via WebEx on developing SOPs for QC lab computerize systems/instruments (Empower 3/ Chromatography Data Acquisitions Systems (CDAS), LabX, DSC, Open Lab & Chemstation, Dickson Ware, IR), and software implementation.
• Supporting IT with developing business procedures, SOPs, Work Instructions, Policies and Standards for new implementation of a manufacturing plant/Labs.
• Traveled to site monthly or as needed to ensure project activities are progressing and to meet with the QC lab owner for each lab systems to ensure the documentation covers the procedure steps, audit trails, and follows GxP regulations, compliance GAMP 5, and CSV processes.
• Routed draft documents to internal/validation teams for review and approvals.
• Maintained project timelines of tasks and completed activities.
• Provided project updates at the weekly project meetings onsite or remote.

Confidential

Senior Compliance Document Lead &Technical Writer

Responsibilities:

• Responsible for creating the Protocols for the execution and implementation of the mass data loads.
• Reviewed various SOPs from global sites tied to the project and ensured the protocols are aligned with the procedures.
• Created digital signatures and fillable pdf forms for the combined protocol and test script prior to execution, as well as route documents for approval in preparation for validation and ADAPTIV QMS readiness.

Senior CSV Compliance Document & Technical Writer Lead

Confidential

Responsibilities:

• Authored Compliance SDLC documents and collaborate with multiple leads on the (Conversion, Migration, and Test) efforts for the compliance document SDLC deliverables per each system in scope.
• Ensured document approvals meet project deadlines. Responsible for routing and management of Document approvals (E-Signatures) required for the various documents generated for the project.
• A Subject matter expert performing with limited supervision in accordance with all applicable companies’ policies, procedures, and guidelines.
• Reviewed author test/scripts by leads prior to uploading into automated test tools (HPALM/Clear Quest system) for execution and data verification/validation.
• Scheduled and managed daily WebEx conference meetings for updates on completion of document deliverables with the various team members, group or one-one as needed to ensure document deliverables were completed per established times.
• Executed good documentation practices (GDP).
• Ensured cross functional teams were in alignment on good documentation practices, this required key stakeholders including IT, Quality, Regulatory Affairs, Project Management, Q-CSV and Business members.
• Ensured quality and compliance on actions/activities, identify report and resolved corrections for any deviations.
• Obtained knowledge in HP TRIM quality compliance document management database; coordinate folders for the final approved SDLC documents to move into HP TRIM, and set document/file properties for informational tracking and searching.

Supplier Quality Compliance (SQC) Lead

Confidential

Responsibilities:

• Supported the External Manufacturer Supplier Audits (EMSA) PM; improved and proficiently transformed approx. 180 documents through technical writing, form designs, revisions, and verification of the supplier audit program procedure and ensured they complied with the Medical Device (MD) Standard Operating Procedure (SOP).
• Succeeded in the completion of all SQC revision documentation, translation, verification and implementation; all SQC documents were coordinated, managed and maintained, as well as communicated with cross functional department team/sites in order to meet project deadlines through WebEx, emails, communicator and phone.
• Processed all documents through Quality Systems (QS) ADAPTIV document management system for final verification, executive level approvals, establish training, and release to effective and close state.
• Value-added to pre-audits reviews, audit reports, quality assessments, audit observations to ensure audit quarterlies are adhered to the audit regulated guidelines, SOP procedures, as well as written memos to file for overdue audit observations, gathered approved signatures and filed accordingly.
• Developed and implemented the new EtQ for CAPA Supplier Audit procedure.

Project Manager Technical Writer Lead

Confidential

Responsibilities:

• Collaborated with cross functional teams (Device History Records, Calibration, Facilities and Maintenance, Process Validation) teams for the Global Remediation Quality Plan (GRQP) Phase I and II projects. Supported PMO manager on Quality Assurance activities/validation and regulatory deliverables associated to team projects.
• Assured the implementation of four Corrective and Preventive Actions (CAPA’s) and various Local CAPA Action Plans (AP) and Effective Monitoring (EM) activities are successful.
• Daily project status updates were presented to the PMO/GMO, as well as prepared status, issues and risks, CAPAs prior to team/executive teams utilizing deck slides (Dashboards with key indicators, Action items list, Risks, NTF (Note To File), NC (Nonconformance) and a project tracking sheet maintained in SharePoint.
• Supported Process Validation team on the validation of procedure documents and MS Excel spreadsheets for GXP/Regulatory Data submission.
• Performed technical writing of SOPs and Respond to FDA letters on objective evidence.
• PAttained document implementation process led by CAPA’s. Apportioned developed gap analysis to Suzhou team for review and completion, as well as monitor progress.
• Assured completion of open and close CAPA activities were completed efficiently by WebEx meetings.
• Final documents were routed and approved through ADAPTIV. Qualified project teams on how to create and route COs (Change Orders) for approvals through ADAPTIV QMS. Performed technical writing of SOPs, and forms procedures to remain compliant.

Senior Technical Writer SharePoint Trainer Lead

Confidential

Responsibilities:

• Trained teams on SharePoint and tasks associated with project (i.e. Microsoft Office professional/Document format).
• Generated written responses to observation audit letters and reviewed CAPAs.
• Authored GxP documents (SOPs, Protocols, Forms, Presentations, etc.) as well as created Effective Monitoring (EM) Protocols for execution at Facilities and Equipment global sites. Routed EM protocols for approval and submitted them to regulatory for final review and Device History File (DHF).
• Verified completed project paper documents were approved, electronically filed, and submitted to regulatory using FDA GxP processes.
• Assisted with global translations and formatting documents with QA standards).
• Assisted cross functional teams with Minitab setup and configurations, as well as design specifications and reporting for validation.

Senior Technical Writer Document Control Expert Lead

Confidential

Responsibilities:

• Continuous focus on document support provided to SME and business work streams (assigned to) for Quality Systems (QS) document deliverables through creations and revisions related to SOPs, training, work instructions, forms, PowerPoint, U.S. Food & Drug Administration (FDA)/CAPA’s, ISO 14155 and other document types.
• Main liaison for all CDC translation requests between TransPerfect, Inc., a Global Translation Company; processed over 500 new/revise English documents converted to multi languages.
• Developed the translation database tracking system in order to maintain all submitted pre and post translation data.
• Assured documents meet CDC template and QA standards, such as template used, included Change Request (DCO) number assigned, correct footers display, revision history is present, and the format styles and grammar were adhered to.
• Accomplished and improved approx. 145 documents through revisions, translation associated with TUV/HUB audit readiness for CAPA projects.

Confidential

Senior Compliance Validation Lead

Responsibilities:

• Lead compliance CSV reviewer and approver of final SDLC documentations prior to submitting for compliance review, ensured all content complied with FDA GxP and/or Prescription Drug Marketing Act (PDMA) Regulations. Oversee and guided project teams on the System Development Life Cycle (SDLC) process and provided advice on the necessary content for various documents, as well as identified the documentation SDLC and GAMP 5 deliverables for implemented quality systems as such according to project plans and completion. Maintain project documentation numbering system. Uphold the documentation storage areas (electronic and hardcopy) Validation Activities (Change Request and Project). Achieved all requested signatures on all documentation that was distributed through the electronic signature process.
• Trained and Qualified project teams in HP Quality Center (HPQC), as well as documentation and validation process ensuring SDLC processes were followed.
• Executed various compliance validation actions in HPQC: Tracked, scheduled, and managed validation issues to ensure commitment the dates were met. Developed project plan and communicates team.
• Keep project team up to date on compliance information.
• Project planned the Computer System Validation activities by tracking the project activities and coordination of tasks.
• Performed and completed QA audits associated with arranged validation metrics for project leads (metrics to be defined), accomplished requirements reconciliation entered into HPQC to requirements contained in documentation, assessed validation scripts to ensure the validation creation process was followed and the appropriate screen prints were present to confirm activity, certified all requirements had at least one associated validation script, collaborated with teams to reconcile pass/fail validation results within HPQC and validation documentation, ensured deviations (defects) were properly entered into HPQC and captured on report documentation, certified deviations (defects) were properly resolved, and documented, approved associated screen prints properly display the results from an independent review, as well as guaranteed all actual results were filled in and conforms the validation step, generated the traceability matrices and work together with project teams to reconcile the data contained within the trace matrices. Remediated projects or validation escalated issues, as well as submitted to project lead, or manager for approval.

Senior Computer System Validation Lead /Project Manager

Confidential

Responsibilities:

• Lead Computer System Validation (CSV) consultant ensured FTP and CAD SDLC process for FDA regulated applications in a GxP compliance environment.
• Performed technical writing of various CSV deliverables and project planning activities for GxP regulated applications associated with validation plans, requirement specifications, software validation scripts (IQ, OQ, PQ), traceability matrix, and summary reports.
• Confirmed the application complied with CFR 21 Part 11 regulations, or follows US CFR 200, 300, or 800 series, as well as supported UAT with high volume application validated environment.
• Used HP Quality Center (HPQC) automated software validation tools to comply with Sarbanes-Oxley (SOX) regulations.
• Imported validated plans/requirements into HPQC using Excel spreadsheets specific format for validation and linked the documents to each other for traceability.
• Maintained knowledge of QA Auditing and CAPA program via eLearning.
• Presented project updates weekly related to CSV deliverables and ensured tasks were on target with project deadlines.
• Managed project team through the validation process, as well as monitor, schedule, resolve validation issues and ensured commitment dates were adhered to.
• Worked closely with the team, as well as assured timely flow of information with project team.
• Managed validation project plan and change management control processes.

Confidential

SharePoint Administrator &Trainer Lead

Responsibilities:

• Subject Matter Expert/Technical writer Lead for the newly developed SharePoint global intranet at Belfour Beatty Capital Group released to approx.
• Successfully build custom web parts, site pages, and data migration (manual transitions).
• Accomplished the first level support to the groups, and training instructional documentation (guidelines, manuals, and helpful tips).
• Established a training tutorial process for hosting a WebEx training session held five days a week, every two hours open to all participants.
• Qualified end users on the use of the SP site providing guidance on how to navigate the new organization collaboration website; to update personal profile information, learn, share and connect with colleagues across the organization, clarified technical questions and answered in a lower level way to communicate effectively with non-technical people.
• Achieved security and administrative tasks associated with developing and maintaining a SharePoint intranet. Attained daily project updates and reported statuses directly to the Director of IT.

Confidential

Senior Compliance Quality Assurance IT & Jira Admin Lead

Responsibilities:

• Lead the Information Management Systems/Technical Systems Unit department, Quality Assurance & Business Analyst ensured efforts for completion of major project development activities; Established business functional specifications to ensure application development meet business requirements using Agile method. Confirmed all developed applications ran as expected in QA and production environments, output reports displayed in PDF format through Appligent - Append Pro.
• Verified and Executed all developer’s code, and code complied with the client coding standards, as well as reviewed each developer’s builds on their development environment to ensure all documents (release notes, SQL codes/stored procedures, dB objects, RDLs, install instructions, servers, schema, etc.) complied successful through SQL Server. Successfully moved builds to QA environment for deployment, executed precise install/rollback instructions, setup and uploaded RDLs in SSRS (Report Manager) to run various SQL scripts when needed for immediate attention. Controlled all QA validation activities related to the application front-end, as well as produced client reports in batches generated in Excel spreadsheets output to ensure code deployment, created indexes/HTMLs and RDLs functioned as expected. Deployed final builds to Prod; ensured all install documents instructions were obvious for DBAs, e-Dels for production and infrastructure implementations. Conveyed daily updates to end users related to the application build deployments and URLs changes, in addition to, qualified business users on new and updated application changes.
• Administrator for JIRA extended training sessions and tech support to business and team members on how to setup JIRA dashboards, application navigations and creating bug issues. Established and delivered shared searches in JIRA as quick search links, as well as kept the team members informed of all project related issues. Functioned as a SharePoint admin, delivered support to cross functional departments, internal and external business members, and developers on site contents, content management, customization with applications and components, and add on. Established business magic tickets for production deployments, as well as created and maintained all QA JIRA bug-tracking issues, exported deviation issues to validate and ensure business requirements meet expectations. Achieved JIRA System Admin tasks; setup & updated user and group role permissions, add workflows, and project specific configurations.
• Completed entire installation web parts; configured list, libraries, and pages, as well as setup user permissions, created assignments, tasks for projects milestones, setup navigation lists for different contents, publish reports, uploaded documents for collaboration between departments, and setup versioning for check in and check out with documents. Assisted developers with code review/ASP.Net, to ensure client specifications were adhered to. Focused on project status weekly, composed project meeting minutes, organized by tasks, and forwarded to inform business and topmost management. Assisted offshore teams with problems and resolution of JIRA issues as needed.