Hello, my name is
John Roberts
Technical Writer and Process Developer with extensive leadership experience in
Aviation, Pharmaceutical and
Medical Device industries.
- John.Roberts@tellwriter.com
- 305-686-5171
About me
Proven technical writer with extensive experience in aviation, manufacturing, and regulatory compliance. Skilled in transforming complex technical concepts into clear, comprehensible content. Demonstrated ability to interact effectively with stakeholders at all levels to ensure document accuracy. Proven record of working under tight deadlines and maintaining organized systems of document revision. I have commercial aviation exposures via technical writing projects within FAA regulated industry. I also have active operational experience in aviation as a helicopter pilot in the U.S. Army and hold a Commercial Instrument certificate. Biotech, Medical Device, Pharmaceutical and Transdermal experience was honed as both a Senior Production Operations Supervisor for FDA regulated product and technical writing contracts and positions.
I evaluate processes, determine where critical metrics should be recorded, and create the forms and procedures to direct processes, support training materials and ensure regulatory requirements are met.
I have a significant understanding of both FAA and FDA regulatory requirements, and practical experience from operational and quality assurance positions in regulated industry. I have extensive experience creating, producing and editing documentation which meets regulatory scrutiny. I have worked with businesses from different niches, including medical devices, transdermal patches, biotechnology influenza vaccine, bilial system guide wires et al.
I am very familiar with the need to convenience compliance through simple, effective procedures and convenient easy-fill forms that reduce errors while collecting data to meet regulatory scrutiny.
What I do
I study your product specifications and manufacturing goals, perform a gap analysis and/or incorporate your pre-existing inspection findings before developing process flows, SOPs, forms and training materials to record critical process metrics which meet regulatory scrutiny. I have extensive operational experience and have taught cGMPs, GDPs, aseptic gowning, and sterile techniques for new hires and annual review.
Process Gap Analysis
If you require a concrete "as is" gap analysis and solutions to ensure procedures capture clear easy-to-execute steps and provide forms/other tools to collect performance and criteria metrics.
Procedures and Forms
If you are looking for a technical writer who has both the production management and quality assurance (Audit, CAPA, Inspection Review) experience to ensure your product's documentation and data critical criteria data collection meets regulatory muster.
Validation / Engineering Support
When you require procedures, forms and other procedural execution documents for clean room and other system validations.
Skills
Recent Technical Writing Projects
Nov 2022 - Jun 2023
Trax USA Corp.; AAR Corp acquired Trax during my tenure
Technical Writer - Help Pages and functional use testing
Set up application use scenarios to test the functionality of different database switches to document help pages when functional as part of an application migration to an online service and, if determined to be non-functional, created bug logs to facilitate online application transition efforts.
Jul 2021 - Nov 2021
Amerijet International Airlines
Technical Writer
Responded to FAA queries from Flight Standards Information Management Systems (FSIMS), Data Collection Tools (DCTs), to support the assessment of a cargo aviation certificate holder under parts 121 of the regulation. Supported the development and editing of Job Cards using xMetaL (XML application) for controlled aviation maintenance, and provided other aviation publication support duties within the technical publications department.
Mar 2018 - Jun 2020
Westaff Staffing & Biorep Technologies
Technical Writer - quality Assurance
Developed procedures, wrote SOPs, and edited manufacturing and quality control documents to comply with operational, ISO 13485 and FDA regulations at a medical device component developer. Responded to CAPA and audit findings, and authored procedures to support clean room commissioning and D.I. Still validation efforts.
Based in Coral Gables, Florida, just minutes from Miami International Airport. Available for international contracts as needed.