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Technical Writers

Kimbrily McDevitt

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Sr. Technical Writer

A seasoned professional with an executive management background, Kimbrily possesses a diverse skill set that includes document writing, editing, and administration, from technical to policy/ compliance to operational level applications. Ten years of experience in designing, implementing, and administrating document management systems in environments of varying compliance levels. She is an ardent self-starter with the ability to think and work with minimal supervision while producing high-quality results in a timely manner. In addition to a professional, energetic work ethic, for her, accountability and high-quality output are key driving principles.

  • Excellent communications and organization skills with strong attention to detail.

  • Accomplish special projects requiring thorough, efficient research.

  • Maintain an electronic database of documents requiring swift and accurate retrieval.

  • Organize, draft, compare, track, and verified documents for consistency and compliance.

  • Evaluate and develop improved techniques and tools for documents control and quality records.

  • Ensure documents follow standard formatting to minimize typographical, input, editing, and other types of errors.

  • Proof/ review document initiations or revisions to ensure basic and/ or specific requirements are met, e.g., header, footer, style, formatting.

  • Manage approvals to ensure organizational documentation infrastructure integrity while maintaining statutory and regulatory compliance.

Cindy Murphy

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Technical Writer

Cindy has experience with project management, cGMP working knowledge, and technical writing. She provides technical writing and quality oversight in support of commissioning, validation, SOPs, INDs, and protocol development. Cindy has extensive experience working with cross functional teams advising, preparing, and submitting INDs, Amendments, Annual Reports, Response to Questions, Package Inserts and Drug Labeling, as well as writing and executing SOPs, and coordinating and assisting team members during writing, editing, negotiating, and final sign-off of documents.

 

  • Creates and updates Standard Operating Procedures for various clients.

  • Supports the development/ revision of commissioning/ validation protocols (FAT, IQ, IOQ, OQ, PQ, and Validation Master Plan).

  • Updates and maintains PTSI electronic library in support of technical writing projects for clients.  

  • Manages cGMP document library for PTSI project projects.

  • Provides technical writing support for GMP Documentation.

  • Ensures that documentation is complete, recorded, and compliant with cGMP regulations.

  • Meets with clients, vendors, and PTSI SME’s in developing, revising, proofing SOP’s, validation protocols, and presentations.

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