01 Nov 2022
Indiana, Indianapolis, 46201 Indianapolis USA


BH: 3725409 MUST BE ABLE TO WORK ON EMPLOYEE BASIS NO C2C 100% REMOTE - WORK PACIFIC TIME ZONEOur Client is expanding and currently seeks anIT TECHNICAL WRITERfor a 6 months assignment with possible extensionsLeverage your TECHNICAL WRITING and DOCUMENTATION experienceto help take your career to the "Next Level" for 2021!Location: (REMOTE- WORK PACIFIC TIME ZONE)Description:Our Client seeks a Technical Writer to take the lead in writing and maintaining records of all development work, including but not limited to requirement documentation, traceability matrix, validation plan, test plan, quality assurance report, user training guides, etc. according to Specialty Genomics Standard Operating Procedures and regulatory requirements.Responsibilities:Work with Developers, Tester, ITQ, and QA.

Gather subject matter content and compile that information into the proper validation deliverable package (Test Plan, Requirements, Design, Test Scripts/Executions, etc.)

Create and maintain document templates.

Performing documentation and style editing to enhance readability for each type of document.

Updating and maintaining documentation to be compliant with the Standard Operating Procedures (SOPs) and regulatory agency guidelines

Facilitating Review and Approval cycles to include updating documents with feedback and gathering signatures.

Requirements:4+ years of technical writing experience.

Knowledge of regulatory compliance requirements in the pharmaceutical and drug development industry.

Familiar with 21 CFR Part 11 (Electronic Records, Electronic Signatures) regulations.

Experience with various validation methodologies (SDLC), and their implementation in an IT organization.

Proven familiarity with computer system validation, Software development lifecycle concepts and their implementation in an IT organization.

Familiarity with quality assurance and quality control.

Excellent verbal, written, presentation, interpersonal skills.

Proven ability to learn new computer software with minimum instruction.

Experience with traditional waterfall model and iterative/agile development methodologies.

Ability to interact with peers, BU customers, and management within the organization.

Demonstrated self-motivation, self-management and organizational skills with showcasing the ability to manage multiple priorities at once.

Candidate must be able to set and meet timelines and be able to negotiate schedule changes in response to Project Demands.

Education: Bachelor's Degree or equivalent work experience.There is no per diem with this position

There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.

MUST be able to work without sponsorship or VISA transfer for this position.

Why Kelly ® ?By partnering with Kelly® Technology, you’ll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today’s most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We’re here to help you gain experience, keep learning, and move your career forward.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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