Technical Writing & Documentation Specialist with 21+ Years

ANDREW WASH

Cell Phone 317-***-****

Email *********@*****.***

Summary:

Two years of Quality Analyst experience with IT Documentation.

Five plus years of validation experience in documentation and installation experience in the pharmaceutical industry.

Four plus years of project management experience in documentation environments.

Twenty plus years of professional technical writing and information technology (IT) experience for the:

oPharmaceutical industry

oSoftware industry

oAviation industry

oInsurance industry

oManufacturing industry

oU.S. Government Department of Defense (DoD)

oIndiana Department of Transportation

oIndiana Family Social Services Administration (FSSA).

Developed on-line and hardcopy user guides for the Indiana Department of Transportation Land Records Systems Office.

Assisted in developing and launching an introductory course for Lincoln Technical Institute.

State and Federal Government:

oState of Indiana – Land Records Department, developed an online help for a custom software

oFederal Government – Naval Air Warfare Center (Aircraft Division) Indy, created manuals and user guides for two aircraft platforms.

Change Management:

oMaintained the lifecycle of documentation from conception to implementation to utilization to retirement in both a pharmaceutical and a manufacturing environment.

LMS Experience:

oAs a member of the Indianapolis Parenteral Manufacturing Learning & Development (IPM L&D) team

Worked with department heads, developed training plans for their department, laying out the training by phase required so that the individual team members were able to complete their training in an orderly and efficient manner.

From manufacturer supplied manuals developed documentation and training for two new pieces of inspection equipment.

Assisted team members in updating training for the various IPM departments.

Education:

Hazardous Waste Management Under RCRA – Craven Community College, New Bern NC

Naval Aviation Schools

Documentum Database – Industry Training Course

Regulus Database – Industry Training Course

Accomplishments:

Awarded the Master Training Specialist designation for knowledge in instructing techniques, course curriculum and testing development, and instructor evaluation

Achieved the necessary comprehensive knowledge and versatility to instruct all courses in the Aviation Support Equipment school

Instructed Automotive and Truck courses for Lincoln Technical Institute. Was certified by ASE as an automotive/truck technician.

Created the technical writing style guide for the Navy Aircraft ES-3A software systems manuals, and over saw its implementation

Security Clearance:

Secret, Personal Reliability Program (PRP).

Secret, Technical writer and Team Lead, avionics upgrade on two Naval Aviation aircraft platforms.

Professional Experience:

Evonik Jan 2025 – Present

Environmental Control Technical Writer

Description: Update SOPs, Training, and Procedures.

Responsibilities:

Working with Chemical Engineers and Environmental Systems Operators updated SOPs, Training, and Procedures to make the information current and the documents relevant.

Curium Pharma US LLC Aug 2024 – Jan 2025

Manufacturing Technical Writer

Description: As part of a team, ensure that all aspects of the manufacturing of the API and final product are accurately documented.

Responsibilities:

Develop, maintain, and update SOPs in support of the manufacturing process of pharmaceuticals.

Write deviations and working with Quality Assurance document the corrective actions required to remain compliant.

Associate - L&D Programs / SOP – Eli Lilly May 2022 – Nov 2023

Technical Writer

Description: Responsible for the creation, coordination, and implementation of learning solutions and SOPs across the assigned business area / function. Provide support to ensure personnel are qualified to perform job tasks and ensure compliance with GQS requirements. In addition, ensure the successful delivery of learning solutions and SOPs to meet all regulatory requirements and commitments. This is in support of Parenteral Manufacturing.

Responsibilities:

Create, revise, and implement SOPs, training, and related documents, ensuring all documents are compliant with corporate / local policies to meet all regulatory requirements and commitments.

Facilitate the review / approval process (including meetings) required to review, reconcile, and resolve SOP, training, and related document issues.

Work with key business partners to understand the key duties and responsibilities to define requirements for personnel qualification in assigned business area / function; ensure implementation and ongoing maintenance.

Consult across the assigned business area / function and the learning community to ensure learning plans align with business plan and strategic direction.

Create, maintain and troubleshoot curriculum architecture and assignment with business partners.

Anticipate and adjust for project / program issues, escalating as appropriate.

Synovia Solutions LLC Indianapolis IN Oct 2012– Jun 2021

Information Technology

Technical Writer / Hardware Support Specialist

Through research of the engineer’s papers and product specific documentation became proficient with the various GPS units and their associated components. With this knowledge assisted clients in troubleshooting the GPS and instructed them on proper use and functions.

Using HelpNDoc software developed and maintained an online help guide to support Synovia proprietary GPS systems for school buses and white fleets to track, manage, and streamline fleet management.

Developed installation, implementation, maintenance, and users’ manuals for Synovia specific hardware.

Developed operator pocket checklists for pre, during, and post trip guidance.

Provided technical support to customers during installation and hard ware support both prior to and after installation.

Ensured quality deliverables meet IT and business expectations.

Skills:

Utilizing FDA, 21 CFR Part 11, ICH Q7A, EU, WHO

Creating RQ, IQ, and OQ documentation for new equipment installation

Developing SOPs

Developed and maintained documentation in support of PR&D IT

Versed in Transmission Control Protocol/Internet Protocol for system and corporation security.

Developing curriculum and testing, software user guides, and on-line help systems.

Utilizing the entire Micro Soft Office suite.

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