Elizabeth C. Arguelles

Rancho Cucamonga, CA *****

Email: ad1wt9@r.postjobfree.com Mobile: 909-***-****

Summary

Writer/editor with over 20 years experience in R&D and software development documentation, SOPs, IFUs, Work and Process Instructions, RFP/RFI responses, technical, QA, and training documents, validation and testing, and marketing communications

Industry experience in healthcare information systems, government, pharmaceutical and medical devices, IVDR, regulatory affairs, geographical information systems (GIS), energy, retail, integration, and tax/fiduciary software

Document management in Agile-type environment

SharePoint experience and expert user of Microsoft Word and other Office applications

Strong spelling, grammar, project/time management, and communication skills

Proficient in FrameMaker and other Adobe products

Professional Experience

GenMark/Roche via ProPharma Group, Carlsbad, CA Nov. 2022 to Sept. 2023 – Remote Technical Writer (Contract) in Design/R&D and Quality to write, review, correct, submit, and process internal documentation, as well as test and validate manufacturing forms.

Invitae, Irvine, CA May 2021 to Jul. 2022 – Remote Technical Writer (Contract) in Document Control responsible for creating and maintaining SOPs, work instructions, and various Regulatory Affairs documents using the Quality Management System (QMS).

Agiloft, Redwood City, CA Jan. to Apr. 2021 – Remote Proposal Writer Consultant responding to complex RFXs, including gathering information from existing RFXs, marketing collateral, product documentation, and technical experts within the company; and supporting the sales rep assigned to the RFX.

Abbott Labs/Immunalysis, Pomona, CA Jul. 2020 to Apr. 2021 – Technical Writer (Contract) participating in Quality Systems Remediation Program to proofread, prepare, create, review, edit, and update Quality and Technical Documents including SOPs, work/testing instructions, Regulatory Affairs documents, Validation Documentation (IQ / OQ / PQ), Technical Reports, and Record Assessment Reports.

Biosense Webster, a Johnson & Johnson Co., Irwindale CA Nov. 2018 to Mar. 2020 – Technical Writer (Contract) charged with preparing technical documents and manuals, Regulatory Affairs documents, maintenance and updates to Instructions For Use (IFUs), ISO compliance, and collaborating with scientific staff to ensure accuracy of product descriptions. Responsible for documenting and managing change requests and Engineering Change Orders (ECOs).

QuadraMed (formerly Misys/Medaphis), Ontario CA Nov. 2009 to May 2018 – Senior Technical Writer/Editor in R&D and software development charged with researching, writing, and editing reference documentation, as well as Release Notes, for QCPR, a computer-based patient record system. Gathered and analyzed HIPAA compliance and other document content information from Subject Matter Experts (SMEs), including product engineers and analysts.

Esri, Redlands CA 2006 to 2009 – Technical Writer responsible for development and maintenance of user documentation for PLTS Foundation, Atlas, Nautical Solution, XML APIs, and other associated GIS products. Attended scrums; gathered information from Subject Matter Experts (product specialists, project managers, release managers, and software developers), and by performing software product testing.

Misys Healthcare (formerly Per-se/Health Data Sciences), San Bernardino, CA 2003 to 2006 –Proposal and Technical Writer/Editor charged with writing, editing, and maintaining reference documents for Misys CPR, a computer-based patient record system and physician order entry solution for an enterprise environment, as well as responding to RFPs/RFIs.

CCH Inc., Torrance, CA 2001 to 2003 – Marketing Communications Specialist responsible for all aspects of marketing writing and editing, including collateral, data sheets, Web site product information, advertising and direct marketing letters, as well as marketing communications database administration. Performed website product information quality assurance and tracked changes and modifications.

SeeBeyond, Monrovia, CA 1998 to 2001 – Proposal Writer responsible for responding to customer requests for proposals (RFPs) and requests for information (RFIs), often with aggressive deadlines; published proposals for distribution. Extensive experience providing marketing information and collateral in network environment; responding to internal and external requests for marketing information; and providing internal support to legal, sales representatives, sales engineers, and other sales and marketing staff.

Education

B.S. Information Systems, University of Redlands, California

A.S. Computer Science, San Bernardino Valley College, California

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