SUMMARY

• Applied expertise in Technical Writing and Web Development.
• Used my experience to build a successful career as a Quality Assurance and Documentation Specialist.
• Managed documents required in highly regulated environments (e.g. pharma, biotech, medical device, financial services).
• Spent the last 16 years collaborating with Subject Matter Experts in a range of functional areas to write/edit a wide variety of GxP - related documents including: SOPs, Work Instructions, Training materials and their associated tests.
• Developed Web sites, course material, job aides, and end user training curriculum.
• Assisted Director of Clinical in conducted internal company audits.
• Audited Trial Master Files
• Excellent grammatical and editing skills.
• Mastered EDMS and related technology.
• Worked with a variety of applications and customized applications.

TECHNICAL SKILLS

Office Applications: Microsoft Office (Word, Excel, PowerPoint, Project); Microsoft Visual InterDev for ASP; WordPerfect; Lotus; Lotus Notes

EDMS and related tools: Documentum; DWK Documentum; GxPharma; Iso Train; SAP; TrackWise; LACES LabWare LIMS; NetDocs; DocCompliance - Qumas

Publishing Tools: Astound; Action; FrameMaker; Quark Xpress; PageMaker; Adobe Products; PhotoShop; HTML Web Page Construction; Front Page; RoboHelp; Visio Professional; Media 100; After Effects; Dreamweaver; iGraphix; Flash; Web Publisher System

PROFESSIONAL EXPERIENCE

Confidential

Responsibilities:

• Responsible for ensuring that Change Notices (CN) are correctly processed.
• Review all documents attached to the CN to assure that they are technically accurate and comply with Good Documentation Practices (GDP).
• Actively contribute to the development and implementation of Confidential Quality report processes as appropriate.
• Support the Quality review, approval, and notification process of reports published in TrackWise.
• Work with Subject Matter Experts (SMEs) to create and edit Standard Operating Procedures (SOP) and Work Instruction (WI).
• Responsible to deliver on time published reports to customers in the required format. This involves troubleshooting issues raised by TrackWise, and providing ad hoc user support to advanced features of MSWord.
• Review protocols, clinical study reports, investigators brochures, posters, and manuscripts.
• Work with Training to develop a Technical Writing training class.
• Produce high quality documents in a timely fashion.

Confidential

Responsibilities:

• Responsible for ensuring that electronically submitted PV reports are compliant.
• Actively contribute to the development and implementation of improved Sanofi PV report processes as appropriate.
• Support the review, Quality Control, approval, and notification process of reports published in DOMASYS.
• Provide DOMASYS/DOMEX and publishing support for all PV reports to include Risk Management Plan, Ad hoc Safety Reports, and Pharmacovigilance System Master File publishing.
• Act as DMS expert for eCTD, PV report publishing, DOMASYS Template coordination, and other report publishing related projects
• Responsible to deliver on time published reports to Public Safety Report customers in required format. This involves troubleshooting issues raised by DMS, and providing ad hoc user support to Global Pharmacovigilance and Epidemiology collaborators in the use of DMS and advanced features of MSWord.
• Ensure tasks and activities are performed according to the Work Instructions, procedures and policies in place. Participate in the writing / updating of quality documents related to PV Publishing activities.

Confidential

Technical Writer

Responsibilities:

• Consult with Subject Matter Experts to edit documents.
• Edit and update Document Control SOPs, Work Instructions, Policies, and Procedures controlled documents
• Research Deviations
• Research and respond to Corrective and Preventive Actions (CAPA)
• Develop and present Training modules.

Confidential

Analyst

Responsibilities:

• Process Change Order requests and document updates in a timely manner
• Assure adherence to documentation standards.
• Coordinate approval routing, follow-up on approvals, communicate status of approval routing daily.
• Escalate approval routing issues/delays.
• Know and follow all regulations and policies that apply to the job.
• Consult with Subject Matter Experts to edit documents.
• Edit and update Document Control SOPs, Work Instructions, Policies, and Procedures controlled documents.

Confidential

SME

Responsibilities:

• Change Request (DCO) processing and final release
• Assure documentation format/template standards and requirements are maintained
• DCO coordination, approval eSignature validation, release activities
• Final release verification and notifications
• Document Number Issuance
• Assist with cross-workstream inter-document impact assessments
• Communicate/coordinate cross-workstream documentation processing
• Process change requests and document updates in a timely manner
• Assure adherence to documentation standards.
• Coordinate approval routing, follow-up on approvals, communicate status of approval routing daily.
• Escalate approval routing issues/delays.
• Know and follow all regulations and policies that apply to the job.

Confidential, Skillman, NJ

Technical Writer/Document Control Specialist

Responsibilities:

• Wrote and edited SOPs, work instructions, test methods corporate policies and other required documents.
• Investigate Corrective and Preventive Actions (CAPA)

Confidential, Parsippany, NJ

Quality Assurance Specialist

Responsibilities:

• Contributor in developing the documentation Quality Systems.
• Wrote and edited SOPs, work instructions, corporate policies and other required documents.
• Wrote and edited SOPs for Regulatory Affairs.
• QC Regulatory Submissions
• Maintained all documents and audits for QA and RA.
• Assisted in internal audits
• Investigated Corrective and Preventive Actions (CAPA)

Confidential, South Plainfield, NJ

Senior Specialist - Quality Assurance

Responsibilities:

• Workflow Coordinator for DocCompliance (Qumas EDMS) ensuring SOPs, work instructions, corporate policies and other required documents are completed in a timely manner
• Maintained all compliance documents in accordance with regulatory and corporate requirements
• Gathered, prepared, and reviewed documents for submission to foreign regulatory agencies and submited to the Sr. Manager - QA for final processing and approval
• Maintained all GxP (GMP and GCP) audits. Assisted in audits of Clinical and Regulatory Trial Master Files, SOPs, and processes to find missing information. These audits addressed any gaps that might negatively effect an FDA inspection.
• Batch records, investigation reports, change control and other required documents in accordance with regulatory and corporate requirements.
• Maintained the tracking system for Change Control, Incident Reports, and Complaints.
• Reviewed batch records and release packaged materials for clinical studies.
• Prepared monthly reports for the tracking of Change Control, Incident Reports, and Complaints.
• Assisted subject matter experts in the preparation of SOPs and Work Instructions.
• Assisted the Toxicology Department in the preparation and editing of required documents including SOPs and regulatory reports.
• Reviewed NDA, IND, Annual Reports, and Safety Reports for accuracy prior to submission.
• Member of the Qumas Electronic Document Management System (EDMS) implementation team.

Confidential, Edison, NJ

Document Management Specialist/Quality Management/Technical Writer

Responsibilities:

• Advised on appropriate documentation requirements at Roche Molecular Systems ( Confidential, NJ); create, manage, and edit documents in EDMS;
• Ensured compliance of documents with all regulatory and corporate requirements.
• Advised on appropriate documentation requirements at Confidential, Inc. (South Plainfield, NJ); create, manage, and edit documents in EDMS (DocCompliance)
• Ensured compliance of documents with all regulatory and corporate requirements;
• Maintained documents and document archive system in a secure manner including distribution of required documents.

Confidential, Pearl River, NY

Documentation Specialist III/Quality Assurance Specialist III

Responsibilities:

• Resolved routine quality issues during document review;
• Reviewed/edited protocols and reports; wrote and reviewed SOP’s; ensured regulatory compliance of documents and reports including investigation report commitments and biennial review requirements;
• Coordinated content management of documents using GxPharma.
• Reviewed Batch Records and addressed any discrepancies.
• Used SAP for inventory control, LIMS for laboratory testing verification, and Trackwise for resolving Incidents and Change Controls.

Confidential, New Brunswick, NJ

Documentation Specialist

Responsibilities:

• Member of the GXPharma/Documentum Electronic Document Management System (EDMS) migration team.
• Migrated documents into Wyeth GXPharma document system;
• Assisted in document standards and requirements; editing, writing and review of documents.

Confidential, New Brunswick, NJ

Web Developer/Web Master

Responsibilities:

• Merck intranet site; created knowledge assessments and user documentation;
• Worked with WebPublisher System and DWK (Documentum). Communicated any issues to supervision.

Confidential, Fort Lee, NJ

Documentation Specialist/Content Development

Responsibilities:

• Wrote quick reference cards and guides for new applications including help text;
• Assisted in development of new hire kit;
• Developed process flow charts for clients; wrote help text; maintained and updated Web based training applications; created knowledge assessments and user documentation;
• Developed content for eLearning site; wrote WebHR Style guide.

Confidential

Sr. Methods Analyst

Responsibilities:

• Developed eCommerce Web site and eLearning site;
• Edited technical documents; managed online documentation projects;
• Developed WBT and created user documentation; supervisory responsibilities.

Confidential, Edison, NJ

Technical Writer, Web Designer/Consultant

Responsibilities:

• Edited financial reports and developed presentations at Merck Pharmaceutical including use online.
• Developed and edited marketing brochures for Bear Sterns including the creation of marketing pieces.
• Edited technical documents for Lucent Technology - Wireless Division including graphics for PDF files for use on intranet.

Confidential, Secaucus, NJ

Technical Writer, Web Designer/Consultant

Responsibilities:

• Edited catalogs developed in Japan for content and English language for final printing;
• Designed and organized catalogs including interactive product catalogs and hyperlink functionality; assisted in the development of the intranet site;
• Consulted with printers in publishing of catalogs. Wrote documentation for design processes.

Confidential, New York

Documentation Specialist/Technical Writer

Responsibilities:

• Customized Enterprise Resource Software for clients; determined documentation requirements; customized and edited software usage instructions.

Confidential, New York

Marketing & Sales Coordinator

Responsibilities:

• Designed and published departmental newsletter; developed multimedia presentations for upper management;
• Developed mailing pieces; planned proposal presentations.