Technical Writer Project Manager

Janet A. McIver

**** ********* ***. #*** * Walnut Creek, CA 94598

Telephone: 925-***-**** email: ************@*****.*** TECHNICAL WRITER

Over 18 years of progressively responsible experience in all phases of technical and regulatory documentation, writing and editing, from conceptual planning to field-test; instructional design; metrics gathering and reporting. Documentation

Standard Operating Procedures (SOPs), user manuals, standards, training materials, work instructions and job aids in a regulated biotech GxP, cGMP, and ISO environment

IQ, EQ, and OQ documentation for medical / laboratory systems and equipment.

Validation, root cause analysis, CAPA / failure investigations, GMP auditing, and liability reduction. Familiarity with ISO 14971 and ICH Q9.

Core Competencies

Grasps technical concepts quickly, translating complex concepts to diverse end users

Strong organizational skills; handles multiple tasks and projects simultaneously

Self-directed with excellent written, organizational and communication skills

Strong interdepartmental coordination and timely deliverables under tight deadlines Technical Skills

MS Project, Microsoft productivity software (Word, Excel, PowerPoint, Visio), Frame Maker, Agile (CDMS), Atlas (EDMS), Veeva (CDMS), Section 508 accessibility standards, SharePoint, WebEx, Teams, Live Link, Maximo, Adobe Illustrator, Remedy Professional Work Experience

Amgen, Quality Assurance, Raleigh, NC, 28401

Technical Writer/Project Manager, November 2023 — November 2024

(contract, remote)

Supported the Digital Quality Management System (DQMS) project pilot roll-out for the evaluation and update of over 4,000 documents during the company-wide document migration from TrackWise to the Veeva platform

Collaborated with document owners, engineers, QA, and other SMES to create and edit

‘Core’ SOPs, Work Instructions (WIs), Standards and Guides describing various Quality Events: Deviation, Product Software Anomaly/Enhancement, Process Monitoring Assessment

Participated in scheduled User/ Testing sessions and incorporated resulting document updates

Organized regular TEAMS and WebEx meetings with stakeholders to review and approve subsequent document updates

Created Regulatory manual forms to mirror WIs to comply with Business Continuity requirements in case of power failure

Edited 125+ Supplementary documents for reference and wording changes to comply with platform migration

Managed document obsoletion in Veeva to coincide with “Go-Live” schedule

Assisted Owners with the creation, completion and approval of Veeva workflows

Tracked and reported project progress using Smart Sheet and Excel ThermoFisher Scientific, QA Policy & Procedures Management, Wilmington, NC 28401 Technical Writer, September 2021 — December 2022 (contract, remote)

Converted 150 global GMP SOPs from former PPD Legacy template to updated ThermoFisher Scientific template

Assigned to support GMP lab (Wisconsin) with instrumentation conversions

Used Veeva EDMS for document assignment, checkout, tracking and storage

Coordinated with international writers, scientists, and SMEs during weekly Teams managerial staff meetings

Janet A. McIver

1251 Homestead Ave. #137 * Walnut Creek, CA 94598

Telephone: 925-***-**** email: ************@*****.*** Johnson & Johnson, Service Repair Depot, Milpitas, CA Technical Writer – Technical Writer-Engineer II, February 2019 — February 2020

(contract)

Conducted research with engineers and technicians on various Lasik tools, equipment, test mules, and systems used in Service Repair Depot.

Wrote Validation protocols: Tooling and Equipment Qualifications (TFs), Equipment Qualifications (EQs), and Decommissioning Reports for Service Depot Lasik equipment.

Conducted Service Depot equipment tests as part of Operation Qualifications (OQs).

Wrote Final Reports upon completion of equipment/system verification.

Prepared Change Control Submission packets and initiated completed COs through Agile.

Maintained progress / status spreadsheet (Excel) to track project development. Cerus Corporation, Laboratory Services Research & Development, Concord, CA Technical Writer/Editor, November 2016 — March 2018 (contract)

Wrote Final Report and Instructions Guide for Vaisala Equipment Monitoring System.

Wrote Validation documents (Protocols and IOQs) for 80+ pieces of laboratory equipment: centrifuges, incubators, cryo-freezers, freezers, and refrigerators.

Wrote Preventive Maintenance procedures for all laboratory incubators (requirement for completion of validation).

Created an Equipment Age Report in Excel indicating year of manufacture for laboratory freezers, presented at annual budget meeting to determining equipment upgrade.

Maintained progress / status spreadsheet (Excel) to track project development. Kaiser Permanente, Inc. IT Finance, Pleasanton, CA Technical Writer/Editor, April 2016 — September 2016 (contract)

Authored and edited internal business and technical process documents in accordance with corporate standards and guidelines.

Updated SharePoint site to reflect latest document and progress status.

Created cross-departmental Roles/Responsibilities (RACI) matrix. Genentech, Inc. Pharmaceutical Technical Regulatory (PTR OBE), South San Francisco, CA Technical Writer/Editor, December 2014 — December 2015 (contract)

Planned, authored and revised internal process documents in accordance with corporate standards and guidelines.

Proofread and edited internal documents for consistency, effectiveness, and quality.

Attended weekly Regulatory team meetings to participate in ‘crowd’ documentation review (for example, licenses, registrations, permits, notifications, etc.) and to determine next steps necessary for Regulatory filing.

Participated in and provided support for continuous process improvement efforts.

Coursework: Workshop: “Operational Excellence” (Lean Six Sigma), Genentech Pacific Gas and Electric Company (PG&E), Gas and Electric Meter Services (GEMS), Fremont, CA (contract)

Senior Technical Writer, August 2013 — March 2014

Authored original training procedures and job aids (300+ pages) for Gas Meter Quality Assurance, Intest, and Out-Test using Microsoft Word, Illustrator.

Collaborated with internal SMEs to understand concepts and processes.

Photographed equipment for use in training documents.

Translated complex procedural information based on business requirements and standards into easy-to-understand, usable documentation.

Certificate: PG&E Human Factored Procedure Writing course. Janet A. McIver

1251 Homestead Ave. #137 * Walnut Creek, CA 94598

Telephone: 925-***-**** email: ************@*****.*** Jones Lang LaSalle (in partnership with Novartis), Facilities Operations, Emeryville, CA Technical Writer/Performance Coordinator, February 2011 — October 2012

(full-time permanent)

Developed user documentation (Microsoft Word) in compliance with ISO, cGMP GxP and FDA guidelines to support installation, maintenance, instrumentation, calibration, engineering, and training functions.

Tracked KPI / SLA performance progress for business unit across national sites (Excel)

Uploaded documents and metrics to department SharePoint site.

Participated in periodic campus wide “walk-throughs” with campus Maintenance Manager.

Novartis, Inc., R&D Operations and Maintenance, Emeryville, CA Technical Writer III, September 2007 — February 2011 (full-time permanent)

Wrote IQ, OQ, PQ documentation for critical and non-critical laboratory equipment and systems. Familiarity with ISO 14971 and ICH Q9.

Laboratory/medical equipment: Ultrafiltration skids, autoclaves, solvent recyclers, freeze dryers, vial-sterilizing machines.

Major/critical systems and equipment: Documentation for installation, performance testing and subsequent validation of major purified water system, resulting in: a. Operation Manual and b. Preventive Maintenance Manual.

Participated in scheduled FDA documentation audits and internal equipment and documentation audits.

Supported the completion of Deviation Reports (DR), Corrective Actions and Preventive Actions (CAPA), identifying Root Cause and translating complex technical concepts into simple language. Familiarity with Federal and State policies and practices (HIPAA).

Wrote, edited and revised SOPs, Controlled Forms, and Managed Documents for the maintenance, support services, customer and end-user activities in accordance with GxP standards and regulations. Used Microsoft Word, PowerPoint, Excel, Atlas EDMS.

Coordinated and supported the development and maintenance of training matrices, plans and records (electronic & paper).

Wrote Seismic Anchoring document for all campus equipment.

Wrote training quizzes for mechanics and technicians.

Developed Workflow Age Report (Excel) to measure document cycle time. Genentech, Inc. Maintenance Operations, Vacaville, CA (contract) Technical Writer, April 2006 — June 2007

Wrote, edited, and revised 200+ Manufacturing, Maintenance, Utilities, and Instrumentation SOPs in accordance with GxP standards. Microsoft Word; LiveLink.

Created and maintained Excel spreadsheet to track document progress through approval flow and monitor SOP status.

Implemented parallel document editing process, resulting in faster document turnaround time.

Successfully met aggressive document deadlines to satisfy strict new commissioned system turnover schedule.

Education

Master of Arts, Education, University of Colorado, Boulder, CO Professional Coursework: “Operational Excellence” (Lean Six Sigma), Genentech. Certificate: Human Factored Procedure Writing, PG&E. Guidance Document Initiative (GDI) Training, PG&E

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