SUMMARY:

• Senior technical writer with over ten years of experience. Expertly utilized advanced technical writing skills and various computer software applications to create, edit, and revise scientific and technical documentation, including Manuals, Standard Operation Procedures (SOPs), Job Aids, User Manuals, Forms, Work Instructions, Operations Guides, and Materials.
• Biotechnology, Medical Device, Pharmaceuticals and Life Sciences Abilities: Over 10 years of technical writing experience in Pharmaceuticals, Biotechnology, and Medical Device.
• Wrote a variety of technical and laboratory documentation, including SOPs, manuals, and batch records for major biotechnology and medical device companies including Confidential, Abbott, Confidential, Confidential, Pfizer, and Confidential .
• Worked collaboratively with project team members including Manufacturing, Engineering, Process Development, Quality and other subject - matter experts, to assemble content used for document creation.
• Wrote and edited numerous scientific and laboratory SOPs.
• Created and edited batch records and laboratory procedures used in pharmaceutical manufacturing.
• Technical Writer in Cybersecurity and Confidential:
• Wrote a variety of procedures used in the operation of natural gas and electric utilities.
• Quality Systems and Database Management: Expertly employed Document Control, Electronic Document Storage Software, and Change Control Procedures.
• Utilized a variety of Database Applications, Electronic Document Storage Techniques, and Electronic Data Management Systems (EDMS), for data migration, storage, and archiving. (e.g., SharePoint, Documentum, LiveLink, and ATLAS).
• Electronically and physically filed and stored numerous documents. Migrated thousands of electronic versions of documents and metadata into new Electronic Data Management Systems (EDMS). Electronically stored documents according FDA regulations.
• Developed, wrote, authored, reviewed and improved technical documentation including Manuals, Standard Operation Procedures (SOPs), Job Aids, Forms, Templates, Operations Guides, Work Instructions, and Materials.
• Expert in Microsoft Word, Excel, PowerPoint, Visio, and SharePoint.
• Organized complex topics and communicated concepts clearly and concisely, conforming to a specific style.
• Interviewed and collaborated with subject-matter experts to obtain information to write content.
• Translated technical information into clear, concise instructions that are standardized easily followed and understood.
• Proofread and edited documents.
• Used photographic materials and/or imaging software for illustrations and creation of procedures.
• Background in IT systems, computer hardware, software and storage systems.
• Prepared charts, graphs, and forms.
• Interacted with Confidential Data Center teams to produce multiple types of professional writing, including, material, manuals, and procedures. Expert in Confidential Docs, Confidential Sheets, and Confidential Drive.

PROFESSIONAL EXPERIENCE:

Confidential, Pleasanton, California

Technical Writer

Responsibilities:

• Created, proofread and edited a variety of documents including procedures and work instructions for a multinational health care company that manufactures numerous medical devices and diagnostics products.
• Abbott manufactures advanced medical devices that replace the function of the human heart.
• Worked closely with engineering team to draft and edit design documents/drawings, process instructions, test reports and protocols, test plans and reports, summaries and final reports.
• Interviewed Subject Matter Experts (SMEs) and conducted research to obtain the content needed to edit and create procedures.
• Formatted documents according to specific company writing style.
• Proficiently utilized Microsoft Word and Adobe Acrobat Pro in document creation.

Confidential

Technical Writer in IT Operations

Responsibilities:

• Expertly utilized a variety of computer software and technical writing techniques used in document creation, editing, proofreading, and revising various types of documentation, including manuals, procedures, templates and instructions used in the operation of medical devices. These medical devices were used to communicate with IT equipment.
• Created and edited workflow diagrams and flow charts using Microsoft Visio.
• Wrote and edited manuals for the operation of various telecom, video conferencing and communication devices used at Zuckerberg San Francisco General Hospital.
• Created help desk / troubleshooting procedures. Wrote troubleshooting scripts to explain how to solve IT issues involving medical devices.
• Wrote computer software usage documentation and technical material.

Confidential, Mountain View, California

Technical Writer

Responsibilities:

• Interacted with Confidential Data Center teams to produce multiple types of professional writing, including, material, manuals, and procedures.
• Edited procedures used in the operation of equipment (e.g., Confidential infrastructure, hardware, servers, storage systems) used Confidential Data Centers.
• Expert in applications including Confidential Docs, Confidential Sheets, Confidential Drive, Confidential Drawings, Gmail, Confidential Calendar, Confidential Chat, Confidential Hangouts and Confidential Slides.
• Worked with management to organize existing documentation, identify deficiencies and prioritize solutions.
• Obtained information by interviewing and collaborating with subject Matter Experts, Confidential Data Center Engineering, Construction, and Operations teams.
• Produced documents that were understood by both technical teams and prepared for external publication.
• Created and used Confidential templates to create a variety of Confidential documentation.
• Edited and proofread procedures and manuals to ensure that they met with the correct Confidential style guides.

Confidential, San Francisco, California

Senior Technical Writer

Responsibilities:

• Wrote Cybersecurity procedures, including corporate security in order to comply with the North American Electric Reliability Corporation (NERC) Critical Infrastructure Protection (CIP) compliance standards.
• Expert in document control, database applications, electronic document storage techniques, and Electronic Data Management Systems (EDMS).
• Interviewed Subject Matter Experts (SMEs) and conducted research necessary to produce accurate, comprehensive documents.
• Expert in Microsoft Word, Excel, PowerPoint, Visio, and SharePoint.
• Added illustrations charts and figures to procedures and job aids to explain the process steps in greater detail.

Confidential, South San Francisco, California

Senior Quality Assurance Specialist / Biotechnology Technical Writer

Responsibilities:

• Wrote, edited and created a variety of documents, including global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulated procedures related to clinical studies for a biotechnology company that uses human genetic information to discover, develop, manufacture and commercialize medicines to treat Confidential ts with serious or life-threatening medical conditions.
• Created a variety Microsoft Excel documents. Cataloged thousands of records into spreadsheets for data migration.
• Independently led cross-functional working group on GCP/GVP processes, providing guidance on overall creation and management of controlled documents (e.g. Standard Operating Procedures).

Confidential, Emeryville, California

Technical Writer

Responsibilities:

• Worked collaboratively with project team members including Manufacturing, Engineering, Process Development, Quality and other subject-matter experts, to solidify content for a biotechnology and pharmaceutical company that provides products to fight more than 20 vaccine-preventable viral and bacterial diseases.
• Created new or revised existing content for Standard Operating Procedures (SOPs) Batch Production Documents, and other technical documents with a high degree of quality in accordance with cGMP requirements and corporate guidelines.
• Responsible for the creation of a variety of technical documentation, including instructions, forms, methods, and procedures.
• Independently researched, wrote, edited and proofread technical documentation.

Confidential, San Ramon, California

Technical Writer

Responsibilities:

• Responsible for the editing and creation a variety of technical documentation, including instructions, job aids, standards, methods, and procedures.
• Researched, wrote, edited and proofread technical documentation.
• Interviewed subject-matter experts and conducted research necessary to produce accurate, comprehensive documents.
• Recorded process steps with a digital camera. Used photographic materials and/or imaging software for illustrating process steps.

Confidential, La Jolla, California

Document Control Specialist

Responsibilities:

• Expertly edited and revised a variety of scientific, engineering, and technical documents to ensure that they met with quality standards and style guidelines for a genetic diagnostics company that designs, develops, manufactures and markets innovative technology, instrumentation for clinical research, In Vitro Diagnostic (IVD) laboratory procedures, and clinical molecular diagnostics markets.
• Conducted change control activities on numerous documents.
• Electronically and physically filed and stored numerous documents. Migrated thousands of electronic versions of documents, stored in SharePoint files, including quality records, batch records, SOPs, work instructions and engineering diagrams, into a new Electronic Data Management System (EDMS), MasterControl.
• Created a variety of Microsoft Excel spreadsheets used for the storing and transfer of Quality metadata.

Confidential, San Diego, California

Technical Writer

Responsibilities:

• Assisted with writing procedures for the operation and construction of Confidential Next Generation Nuclear Plant (NGNP) project. Expertly applied a variety of technical writing skills used to edit, correct and improve scientific and engineering documents.
• Read and understood a variety of engineering diagrams, figures, schematics, and technical drawings, and placed them into documents to clarify and illustrate process steps.
• Converted documents written in PDF format into Microsoft Word.
• Wrote numerous Microsoft Excel charts and tables relating the operation of the Nuclear Power Plant.

Confidential, San Diego, California

Technical Writer / Quality Assurance Specialist

Responsibilities:

• Translated technical information and new concepts and techniques obtained by interviewing subject-matter experts and scientists, researching information, and obtaining scientific documentation, into clear and concise instructions and documents that were standardized, easily followed and understood by a variety of scientific and laboratory personnel.
• Created, edited, developed, and revised documents, work instructions, batch records, forms and laboratory SOPs to improve scientific procedures, methods and laboratory techniques in the areas of biological sciences, stem cell research, biotechnology, laboratory instrumentation, molecular biology, and laboratory assays.

Confidential, San Diego, California

Technical Writer / Quality Assurance Specialist

Responsibilities:

• Conducted Master Filing and Document Control by maintaining paper archives, controlled documents, and electronic databases, and by revising scientific documentation, including laboratory procedures, SOPs, and work instructions.
• Wrote, developed, and edited documentation relating to quality systems.
• Transferred paper documents into an electronic form for document archiving. Routed and archived documents.
• Updated and maintained existing documentation to ensure that it was technically accurate properly addressed the target audience and conformed to the corporate style guide.

Confidential, La Jolla, California

Quality Assurance & Compliance Department

Responsibilities:

• Expertly employed SOPMAN, LiveLink and Documentum computer software Document Management Systems (DMS) for the tracking and storing of electronic documents (e.g., electronic records, quality assurance, scientific, and research reports, and SOPs) and/or images of paper documents for document archiving, database management and document control.
• Entered metadata into hundreds of data fields into new global Electronic Document Management Systems (EDMS).
• Electronically stored documents to enable access by Pfizer scientists. Used EDMS software to assist scientists with a global pharmaceutical data storage and retrieval project.
• Transferred and archived over 2000 scientific and technical documents to new EDMS file locations.
• Created and organized Microsoft Excel databases to identify documents and to track data metrics progress.

Confidential, Mountain View, California

Biotechnology Technical Writer / Project Leader (Contract position)

Responsibilities:

• Observed and troubleshooted advanced molecular biology assays (e.g., ELISA, electrophoresis, protein concentration determination) requiring precise analytical skills and the understanding of biology and chemistry principles for an established biotechnology company that creates a variety of products with a focus on the study of gene and protein functions, research reagents and assay kits with applications for genomics, functional genomics, and drug discovery.
• Created and revised documents, work instructions and laboratory SOPs in order to improve scientific procedures, methods and laboratory techniques in the areas of biological sciences, biotechnology, laboratory instrumentation, molecular biology, and laboratory assays.
• Proficiently utilized computer software applications in the creation and revision of technical documentation (Microsoft Word, Microsoft Excel, Photoshop, and Q - Pulse).
• Employed Electronic Document Storage (EDS) techniques, and Electronic Data Management Systems (EDMS), for data migration, archiving, and storage.
• Researched computer databases, online search engines, library documentation, and interviewed and collaborated with senior scientists in order to obtain the necessary information used in the creation and revision of laboratory assays.