ANDREW WASH

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

Email adyhaz@r.postjobfree.com

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.

Instrumental in developing and implementing curriculum and testing criteria for U.S. Navy Aviation Support Equipment Courses as part of a complete curriculum rewrite.

Education:

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

U.S. Navy Schools - Basic Electricity and Electronics, Aviation Support Equipment Electrical and Air-conditioning, Motor and Engine Driven Generators, Avionics Corrosion Control, Work Center Supervisor, Group Paced Instructors Course

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 1983 – 1991, Personal Reliability Program (PRP).

Secret 1995 – 1997, Technical writer and Team Lead, avionics upgrade on two Naval Aviation aircraft platforms.

Professional Experience:

Associate - L&D Programs / SOP May 2022 – Apr 2023

Technical Writer

Description: The Associate – Learning & Development (L&D) Programs / Standard Operating Procedures (SOP) is responsible for the creation, coordination, and implementation of learning solutions and SOPs across the assigned business area / function. This role provides support to ensure personnel are qualified to perform job tasks and ensure compliance with GQS requirements. In addition, this role ensures the successful delivery of learning solutions and SOPs to meet all regulatory requirements and commitments. This role supports Parenteral Manufacturing.

Responsibilities:

Identify, analyze, and determine learning solutions and methods to resolve potential performance gaps.

Create, revise, and implement SOPs, training, and related documents, ensuring all documents are delivered on-time, follow established format and template, and 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.

Participate regularly in area / function project and process teams.

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.

Basic Qualifications:

Bachelor’s Degree (or 5 years Pharma experience).

Experience in technical writing.

Demonstrated ability to establish strong business relationships.

Ability to work independently and in a team environment.

Knowledge and understanding in following IPM HEP (Human Error Prevention) SOP’s and TOOLS.

Strong organizational skills.

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

Utilizing the entire Micro Soft Office suite.

Contact this candidate