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Kelly Steffen


As the PTSI Administrative Assistant, Kelly reports to the CEO supporting PTSI Engineering, Manufacturing, Process Development, and Quality/ QC teams. She manages the PTSI Onboarding process and issues PTSI emails to new team members, trains new team members on using Office365 and Outlook/ Microsoft Teams, updates and manages the PTSI website, develops and revises team resumes/ bios, coordinates company meetings, assists in troubleshooting technical issues with Outlook and OneDrive, and keeps track of all other miscellaneous Admin activities. She is an experienced administrative assistant, business project manager, and technical writer with excellent computer, verbal, and written communication skills as well as interpersonal skills and customer orientation. She demonstrates excellent attention to detail, organization, and planning skills, and is action oriented, approachable, and demonstrates commitment to the success of the team over personal success.

Kelly provides consulting services as the Document Control/ Technical Writer PM supporting clients with project documents, presentations, and high-level schedules. Duties include establishing and maintaining PTSI templates, developing and updating Standard Operating Procedures (SOPs), updating and utilizing the PTSI electronic library in the development of Basis of Design, Request for Proposal, User Requirement Specifications, Design Specifications, Integrated Project Schedule, performance Dashboards, A3’s, Bid Assessments, Risk Assessments, CMMS Job Plans, Validation documents, and training modules as required. With advanced knowledge of Microsoft Office (Word, PowerPoint, Excel, Outlook, Visio, Project, and OneDrive) she provides technical writing support for cGMP documentation ensuring all documentation is complete, recorded, and compliant with cGMP regulations, and establishes and maintains the projects’ Master Equipment/ System List. Provides cGMP Biopharma experience in providing review of technical documents, creates user documentation and how-to guides, meets with client MFG, ENG, QA, and QC SMEs in developing, revising, and proofing cGMP documents, and ensures technical verbiage is easy to understand by all team members. She supports in the creation of commissioning cGMP-controlled forms, scheduling trackers, providing SOP/ Cx documents weekly project reports, and keeping track of due dates and action items for the team.

Experienced business management professional with working knowledge of project contracts/ proposals, accounting principles, and strong client interaction communication skills. As the PTSI Business Office Manager, Kelly issues clients CDAs, completes the process, and organizes completed CDAs, establishes and maintains the PTSI Proposal and Contract templates, processes Proposals/ Contracts, routes for internal approval, issues to clients, and completes the contracts, and processes other sensitive and confidential documentation. Develops/ processes Master Service Agreements, sub-contractor specific project contracts, and supports the Chief Financial Officer in maintaining the PTSI invoice tracker, organizing timesheet and expense report submissions, and managing the processing of invoice payments on schedule. She trains new PTSI sub-contractors on PTSI timesheets, expense reports, and invoice processes, and maintains the Project Tracker responsible for keeping track of end dates and remaining funds for projects. She is able to work independently in a matrix environment and manages multiple tasks simultaneously.


Kelly received her Bachelor of Science degree from the University of California, Davis.

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