Kaisa Cardall
Document Control Specialist at TJO - Total Joint Orthopedics- Claim this Profile
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Bio
Experience
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TJO - Total Joint Orthopedics
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Document Control Specialist
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May 2023 - Present
• Establish and provide document control support to authors and process owners in defining and producing lean Quality System documents and records • Ensure and provide direction regarding proper quality of the content of documentation and records • Establish and manage proper document review processes • Ensure availability and publishing of controlled documents • Monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business • Maintain documents and records of the latest revision level in TJO’s eDMS • Maintain the document management system and ensure fast retrieval of documents and records • Control issuance of document numbers, including maintenance of proper document registers • Ensure proper document classification, sorting, filing, and archiving in accordance with quality requirements • Review correct formatting and completeness of documentation • Document support for regulatory audits • Perform quality activities for product release • Create LHR’s, receive and verify certs Show less
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Business Owner
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Jan 2020 - Present
• Founded Libre Kids Co., a successful kids clothing and accessories online store. Run day-to-day operations, including budgeting, sales, customer service, marketing campaigns and social media accounts. • Built and launched a successful e-commerce retail site • Negotiated contracts and built relationships with vendors and local small businesses to procure items for the business and for resale. • Founded Libre Kids Co., a successful kids clothing and accessories online store. Run day-to-day operations, including budgeting, sales, customer service, marketing campaigns and social media accounts. • Built and launched a successful e-commerce retail site • Negotiated contracts and built relationships with vendors and local small businesses to procure items for the business and for resale.
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Stay-at-Home Parent
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Jan 2014 - Jan 2023
• Manage multiple schedules for a household of two adults and three children. • Create daily routines with built in flexibility • Establish budgets for utilities, food, necessities and leisure activities • Balance caregiver duties with freelance and small business work • Manage multiple schedules for a household of two adults and three children. • Create daily routines with built in flexibility • Establish budgets for utilities, food, necessities and leisure activities • Balance caregiver duties with freelance and small business work
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Veracity Solutions
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United States
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Software Development
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1 - 100 Employee
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Executive Assistant To Chief Executive Officer
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Mar 2011 - Jan 2014
• Participated as an adjunct member of the Executive Team including assisting in scheduling meetings and attending all meetings. • Completed a broad variety of administrative tasks for the President & CEO including: managing an extremely active calendar of appointments; completing expense reports; composing and preparing correspondence that is often confidential • Communicated directly, and on behalf of the President and CEO, with board members, donors, foundation staff, and others, on matters related to CEO's programmatic initiatives. Show less
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Document Control Technician
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Jan 2008 - Sep 2010
• Assisted Director of Regulatory Affairs and Quality Assurance. • Developed and evaluated work-related SOPs and training materials, as required. • Processed proposed document change orders and manage related filing system. Acted as software administrator of document control system. • Performed audits on manufacturing production work orders and other QA assignments as necessary. • Assisted Director of Regulatory Affairs and Quality Assurance. • Developed and evaluated work-related SOPs and training materials, as required. • Processed proposed document change orders and manage related filing system. Acted as software administrator of document control system. • Performed audits on manufacturing production work orders and other QA assignments as necessary.
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NPS Pharma
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United States
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Biotechnology Research
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1 - 100 Employee
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Sr. Document Control Specialist
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Sep 2003 - Aug 2007
• Electronically published medical writing and regulatory documents for domestic and international submission including study protocols, investigator brochures and NDAs. • Formatted clinical documents that were in accordance with applicable SOPs and that adhered to company policies and style guidelines. • Integral member of clinical document preparation teams that include regulatory affairs, statistics and data management and clinical operations. • Implemented efficient and effective document management and archivist practices and procedures in accordance with GLP guidelines. Show less
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Education
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University of Utah
Web Design Tools Certification -
Salt Lake Community College
Associate's degree