Project Manager Quality Assurance
Resume:
Lisa M. Ferreira
** ******** **** ****: 908-***-****
Hackettstown, NJ 07840 Cell: 908-***-****
qi4o99@r.postjobfree.com
SUMMARY
Worked in a global organization with experience in the US and Europe. Excellent knowledge of GLPs and FDA submission process. Impressive people skills and ability to communicate complex ideas to management. Talent for structuring and implementing programs/policies that drive the business forward.
EDUCATION:
PhD Candidate, Organization & Management
Capella University (Current GPA 3.72)
Minneapolis, Minnesota
MBA, Information Technology Management - 2007
Capella University
Minneapolis, Minnesota
BS, Business Administration - 2006
Cum Laude – Capella University
Minneapolis, Minnesota
PROFESSIONAL CERTIFICATION:
Drug Development for Johnson & Johnson
Pharmaceutical Education & Research Institute, Inc.
Senior Regulatory Documentation Specialist / Novartis Pharmaceuticals Corporation
Senior Scientific Publisher East Hanover, NJ
Documentation / Translational Sciences
March, 2007 – October, 2009
• Interact closely with Translational Sciences (TS) scientific personnel (Study Directors, project team representatives) in the preparation of nonclinical and clinical regulatory documents, e.g., INDs, CTAs, CTDs, eCTDs and reports of studies conducted by TS or contract laboratories.
• Project Manager on multiple Regulatory projects in US and EU.
• Installation Qualification, Operational Qualification and Performance Qualification testing on various systems.
• Trouble-shoot and resolve issues pertaining to system errors.
• Preparation of templates for study reports, summaries and other regulatory documents.
• Coordination of activities and processes within the Global TS line unit.
• Participation on local and global teams and interactions with other line units, e.g., DRA, on submission activities.
• Training of TS associates to ensure understanding of publishing requirements.
• Assist in updating report and protocol templates, coordinate global templates, and provide instruction to end-users.
• Working knowledge and compliance with Good Laboratory Practice and Standard Operating Procedures.
• Processing, publishing, and quality checking submission documents.
• Lead special projects as assigned, such as assessment of new technology, electronic submissions and technology validation.
• Recommend process changes to enhance efficiencies in the group.
• Maintained effective interactions with the Regulatory Team, Study Directors and Business Units.
• Ability to work within and maintain an effective team environment. Organize, prioritize and meet deadlines.
• Skill in establishing effective working relationships with others.
PROFESSIONAL EXPERIENCE:
Dossier Senior Analyst/Lead Publisher Johnson & Johnson Pharmaceuticals
Electronic Submissions & Publishing Operations Research & Development
2004 – 2007 Raritan, New Jersey
• Ensured that 100% of project deadlines were met through regular interactions with scientific staff, Quality Assurance Representatives, PCD Leaders & Preclinical Writers.
• Extensive experience with Contract Research Organizations (CROs) to ensure compliance to J&J standards and on-time delivery of results.
• Developed workflow process for CRO/ExPRD Reports, which resulted in compliance with the regulated document format for the company.
• Developed J&JPRD Reports Supporting CRO Study Workflow Guideline, Developed Issue Date Notification Workflow, Developed ExPRD Title Page template to adhere to departmental needs.
• Developed Process for Quality Assurance Statements/Good Laboratory Practice Conformance Statements for CRO/ExPRD Reports to ensure consistency and efficiency for the company.
• Ensured timely delivery of documents that have met the dossier standards for formatting, quality, and review, according to established procedures.
• Ensured the completion of submission related study reports in order to meet submission milestones by ensuring that scientific staffs were notified of submission deadlines and assisting with report processing.
• Provided training and consultation on electronic submission requirements to Preclinical colleagues in US/EU in accordance with FDA/HA requirements.
• Executed the electronic assembly and production of preclinical research reports and submissions for worldwide customers according to departmental submission requirements and the Global Dossier Plan.
• Planned and assembled requirements for research reports and submissions using appropriate document management tools (Documentum [GRIPS], ISI Toolbox, Ultralinks, Adobe Acrobat, Core Dossier) for internal document reviews & assisting with the review process.
• Initiated project management for submissions within Preclinical by creating content plan process for use with assisting Regulatory Operations with locating Preclinical submission components.
• Extensive knowledge regarding the dossier assembly/production process and the structural organization, standards and requirements of regulatory dossiers.
• Maintained effective interactions with the Regulatory Team, primarily through the Regulatory Coordination Member, to ensure priority conflicts, resource issues and deviations from the plan are identified, communicated and resolved to minimize impact on submission dates.
• Participated in development of department policies and objectives.
• Demonstrated project management skills. Strong commitment to customer responsiveness. Strong team player and eager to learn new tasks.
• Project Managed submission-related Preclinical study reports to ensure to meet submission deadlines by liaising with scientific staff and Regulatory.
• Pilot Test Various Software (ISI Publisher, Insight Publisher, CoreDossier, DocXamine, etc.)
• Trouble-shoot and resolve issues pertaining to system errors.
Compliance Associate/Publisher Johnson & Johnson Pharmaceuticals
Compliance Department/Electronic Submissions Research & Development
& Publishing Operations Raritan, New Jersey
2002 – 2004
• Responsible for providing support to the compliance and scientific objectives of the department. This includes maintaining Standard Operating Procedure Manuals, updating the Master Schedule, data storage and transfer procedures, final archiving, and information retrieval.
• Responsible for the review, routing, distribution and filing of GMP/GLP documentation. Updated and maintained document tracking databases and archival systems.
• Prepared, routed, and tracked documentation packages throughout review and approval cycle. Distributed approved documentation to appropriate personnel, tracked receipt of documentation, and maintained distribution matrices.
• Maintained hard copy and electronic document files. Issue controlled Production Documentation to Manufacturing and Laboratory Notebooks to Quality Control; maintain records of issuance.
• Initiated and tracked Periodic Document review, to ensure documents are reviewed and revised to reflect current procedure or made obsolete, as necessary. Conduct periodic audits of documentation binders to assure they are current and complete.
• Attended GMP/GLP training programs as required.
• Executed the electronic assembly and production of preclinical research reports and submissions for worldwide customers according to departmental submission requirements and the Global Dossier Plan.
• Project Manager for submission documents for business unit.
Chargeback Adjuster Schering–Plough Pharmaceutical Company
Credit/Claims Department Cranford, New Jersey
2000 – 2002
• Work independently with minimum supervision. Interpret, review, analyze and compute disputed items for Schering and Warrick Chargeback claims with authorized Wholesaler Prime vendors as specified by Terms and Conditions within designated time frames (30-60 days from receipt of claims).
• Communicated and resolved all outstanding issues with Trading Partners, MCAM’s, Trade Directors, Contracts and Pricing and other departments within Schering and Warrick.
• Ensure accurate calculation of credits and rebills issued outside the CCB System.
Documentation Analyst Schering–Plough Pharmaceutical Company
Chemical Development Union, New Jersey
1999 – 2000
• Edit and modify Control Manufacturing Compliance (CMC) and Standard Operating Procedure documents.
• Keep track of lifecycle of Control Manufacturing Compliance (CMC) documents and SOP documents in Documentum. Update and distribute copies of finalized Control Manufacturing Compliance (CMC) documents and SOP documents. Assign EDMS #’s via Documentum.
• Issuance of final Control Manufacturing Compliance (CMC) and SOP documents. Documentation filing and preparation. Documentum and WRAPS literate. Publish Control Manufacturing Compliance (CMC) documents using WRAPS publishing tool.
• Modify highly confidential Control Manufacturing Compliance (CMC) documents to comply with FDA standards and requirements.
• Batch sheet copying and filing.
Finance Assistant Warrick Pharmaceutical Company
Finance Union, New Jersey
1997 – 1999
• Assist finance group with various finance duties. Create spreadsheets in excel, meet deadlines, typing, data entry.
• Distribute daily reports, audit expense reports.
• Developing and revising Account Information Forms for price/rebate change approvals. Create new contract database for accounts.
• Monitoring all inventories located in the Distribution Center.
PROFESSIONAL AFFILIATIONS:
J&JPRD GRIPS Working Group
J&JPRD GRIPS Cleanup Initiative
J&JPRD Publishing Taskforce
J&JPRD Submission Process Team
J&JPRD Submission Process Linking Sub-Team
Active SIAC Member of Drug Information Association
Active Member of Regulatory Affairs Professional Society
Active Ambassador of Capella University
SOFTWARE PROFICIENCIES:
Microsoft Office Suite, Core Dossier, Documentum [GRIPS], PREDI, Adobe Acrobat Suite, ISI Toolbox, Ultralinks, Paper Port, Citrix, Eroom, Visio, DocXamine, ISI Writer, OPX2, MASC, Webedi, ISI Publisher
TRAINING/WORKSHOPS/SEMINARS:
ESOPS WBT (web-based training), 2007
Capella University Colloquia, 2008
Capella University Colloquia, 2010
AWARDS:
2009 Above & Beyond Award for Project Management
2008 Above & Beyond Award for Team Work
2008 Above & Beyond Award for Outstanding Diligence
2007 Above & Beyond Award for Achieved Results
2006 Submissions Department Award for Excellence and Star Performance
2006 Encore Award in Recognition for Customer Focus in eCTD IND Submission
2006 Encore Award in Recognition for Special Achievement in eCTD Submission
2006 Encore Award in Recognition for Teamwork in IND Submission
2006 Encore Award in Recognition for Achieved Results in eCTD Submission
2006 Department Red Carpet Award for Outstanding Performance
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