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Work Background
Sr. Associate, Business Analyst
PFIZER LABORATORIES PFESr. Associate, Business Analyst
Dec. 2023Manage clinical systems, with a focus on Veeva Vault Clinical • Provide general Regional Clinical Trial Operations systems expertise and support • Assist in the planning and implementation of software and systems in Regional Clinical Trial Operations • Participate in clinical system validation projects and other compliance efforts • Develop a deep understanding of clinical system configuration, how it supports current business processes, and how it can be leveraged to support growing organizational needs • May serve as System Owner or delegate, responsible for ensuring validated state • Serve as contact for clinical systems during internal and regulatory audits and inspections • Manage change control and collaborate with other business process owners to ensure process alignment • Drive continuous improvement of clinical systems (projects, maintenance updates, triannual configuration updates) • Triage clinical system issues and drive resolution • Work cross-functionally with IT and Veeva Vault department representatives across Seagen to serve as Subject Matter Expert for Veeva Vault Clinical • Create and maintain guidance for clinical systems to support user adoption, increase compliance, and ensure long-term reliability of data • Update validation lifecycle documents to ensure Veeva Vault Clinical remains compliant and meets the needs of users • Represent clinical systems in cross-functional teams and represent company interests with vendor teams • Troubleshoot to resolve clinical system-related problems; coordinate with relevant IT staff and/or third-party vendors regarding user support and problem resolution
Sr. Specialist, Clinical Systems
Seagen acquired by PfizerSr. Specialist, Clinical Systems
Oct. 2021 - Dec. 2023Bothell, Washington, United States• Manage clinical systems, with a focus on Veeva Vault Clinical • Provide general Regional Clinical Trial Operations systems expertise and support • Assist in the planning and implementation of software and systems in Regional Clinical Trial Operations • Participate in clinical system validation projects and other compliance efforts • Develop a deep understanding of clinical system configuration, how it supports current business processes, and how it can be leveraged to support growing organizational needs • May serve as System Owner or delegate, responsible for ensuring validated state • Serve as contact for clinical systems during internal and regulatory audits and inspections • Manage change control and collaborate with other business process owners to ensure process alignment • Drive continuous improvement of clinical systems (projects, maintenance updates, triannual configuration updates) • Triage clinical system issues and drive resolution • Work cross-functionally with IT and Veeva Vault department representatives across Seagen to serve as Subject Matter Expert for Veeva Vault Clinical • Create and maintain guidance for clinical systems to support user adoption, increase compliance, and ensure long-term reliability of data • Update validation lifecycle documents to ensure Veeva Vault Clinical remains compliant and meets the needs of users • Represent clinical systems in cross-functional teams and represent company interests with vendor teams • Troubleshoot to resolve clinical system-related problems; coordinate with relevant IT staff and/or third-party vendors regarding user support and problem resolution
Clinical Records Specialist
SeagenClinical Records Specialist
Mar. 2020 - Oct. 2021Bothell, Washington, United States• Develop and support training materials and activities related to Veeva Vault Clinical and Clinical Records across departments • Recommend system enhancements / records management process improvements • Support system activities, including formal change requests, updating controlled documents, validation testing and deployment, and change management • Serve as subject matter expert (SME) team members, departments and other Veeva Vault Clinical system users. Including troubleshooting and resolving issues, identifying gaps or areas for continuous improvement. • Lead study team TMF-related activities • Develop and maintain Veeva Vault Clinical and Clinical Records related curriculums • Maintenance of the Trial Master File (eTMF and CTRC) which includes the following: - Carry out cross-functional training to set expectations for filing in the Trial Master File incorporating ALCOA-C standards - Manage the controlled access process, including training and monitoring • Collaborates with peers and Trial Master File users across departments • Utilize system technology and analytics to monitor document quality, identify trends and report to management • Creates reports/dashboards to support efficient oversight for functional groups, study teams, and continuous process improvement • Independently strategizes methods and procedures on new assignments • Lead Clinical Records projects as assigned: - Records retention - Migrating paper-based studies to electronic Trial Master File - Manage and maintain the laboratory document processes - Train on systems across functional groups and external users • Participate in system administration and ad-hoc meetings to report on status, demonstrate functionality, and/or gather requirements for new or updated features • Adhere to company and regulatory guidelines, policies, and quality documents
Clinical Records Specialist
SeagenClinical Records Specialist
Jul. 2019 - Mar. 2020• Maintenance of the Trial Master File (eTMF and CTRC) which includes the following: - Perform routine document quality control in the eTMF and routine system tasks - Manage the controlled access process, including training and monitoring - Maintain study file structure process - Manage record archival and retrieval processes • Utilize system technology to monitor document quality, identify trends and report to management • Determine methods and procedures on new assignments. • Lead Clinical Records projects as assigned: - Records retention - Migrating paper-based studies to electronic Trial Master File - Manage and maintain the laboratory document processes • Support eTMF health and maintenance • Adhere to company and regulatory guidelines, policies, and quality documents (e.g., SOPs, work practices, training guides)
Lead Document Control Specialist
AltasciencesLead Document Control Specialist
Jan. 2018 - Dec. 2019Everett, WA• Develop and oversee the maintenance, editing, review and administration of documents maintained in MasterControl including but not limited to SOPs, analytical methods, forms, and policies. • Develop and oversee the maintenance of curricula vitae, job descriptions and training record files for all employees. • Oversee the maintenance of the company-wide Signature Log. • Maintain company organization chart. • Prepare and update SOPs for document control activities. • Manage the notification and distribution of controlled documents (e.g. SOPs, forms). • Manage the process of verification of the controlled document binder sets to ensure accuracy. • Prepare and update controlled and library documents within MasterControl. • Prepare training records, SOPs, two-year SOP review and other Document Control information to present to Sponsor and regulatory agency representatives as requested. • Participate as company representative on in-house regulatory visits. • Perform training of staff by conducting training seminars and distributing information on GLP regulatory requirements for document control processes. • Act as gatekeeper for assigned departments’ incidents and deviations. • System Administrator for MasterControl. • Maintain computerized files to support and maintain archive processes. • Receive, review, index, label and archive study and facility materials. • Checking of materials in and out of the archives. • Coordinate and document the disposition of study materials according to sponsor’s request. • Identify and recommend new ideas and changes for the department. • Review and update archiving standard operating procedures. • Verification of study materials authorized for disposition. • Support sponsor and regulatory visits by retrieving data from the archives. • Configure and troubleshoot MasterControl for current needs. • Attend annual MasterControl Summit for continuing education.
Senior Document Control Specialist
SNBL USA, Ltd.Senior Document Control Specialist
Jan. 2018 - Dec. 2018• Develop and manage the documents maintained in the Document module in MasterControl including but not limited to SOPs, analytical methods, forms, CV, Job Descriptions. • Manage the notification and distribution of controlled documents (e.g. SOPs, forms). • Manage the process of verification of the controlled document binder sets to ensure accuracy. • Coordinate with other departments to ensure curricula vitae, job descriptions and training files are up-to-date for the company. • Prepare and update controlled and library documents within MasterControl. • Prepare training records, SOPs, two-year SOP review and other Document Control information to present to sponsor and regulatory agency representatives as requested. • Identify and implement process improvement ideas/changes for Document Control. • Assist with providing department training records and company SOPs to sponsor and regulatory agency representatives. • Assist Archive staff with archive checkouts and submissions. • System Administrator for MasterControl. • Configure and troubleshoot MasterControl for current needs. • Attend annual MasterControl Summit for continuing education.
Senior Document Control Specialist
Altasciences Preclinical Seattle LLC Senior Document Control Specialist
Jan. 2018 - Dec. 2018• Develop and manage the documents maintained in the Document module in MasterControl including but not limited to SOPs, analytical methods, forms, CV, Job Descriptions. • Manage the notification and distribution of controlled documents (e.g. SOPs, forms). • Manage the process of verification of the controlled document binder sets to ensure accuracy. • Coordinate with other departments to ensure curricula vitae, job descriptions and training files are up-to-date for the company. • Prepare and update controlled and library documents within MasterControl. • Prepare training records, SOPs, two-year SOP review and other Document Control information to present to sponsor and regulatory agency representatives as requested. • Identify and implement process improvement ideas/changes for Document Control. • Assist with providing department training records and company SOPs to sponsor and regulatory agency representatives. • Assist Archive staff with archive checkouts and submissions. • System Administrator for MasterControl. • Configure and troubleshoot MasterControl for current needs. • Attend annual MasterControl Summit for continuing education.
Document Control Specialist
SNBL USA, Ltd.Document Control Specialist
Jan. 2016 - Dec. 2018• Develop and maintain computerized files to support all documentation systems including: training records, standard operating procedures (SOPs), reference materials, certificates of Analysis, Job Descriptions, Curricula Vitae, etc. • System Administrator for MasterControl. • Oversee the maintenance, editing, review, administration and distribution of documents within MasterControl. • Identify and recommend new ideas and changes for Document Control and Training. • Assist with MasterControl Training module initiation and maintenance. • Act as gatekeeper for Document Control and other departments for incidents and deviations. • Configure and troubleshoot MasterControl for current needs. • Create and maintain training and user profiles in MasterControl. • Maintain and verify the Document Control indexes and binders. • Prepare and submit archive data. • Maintain and verify all indexes. • Assist the Archive department with checkouts, and material transfer and destruction. • Act as a resource for employees regarding MasterControl and Document Control processes and features. • Attend annual MasterControl Summit for continuing education.
Production Coordinator
Innovative Kitchens and Bath Ltd.Production Coordinator
Jan. 2015 - Dec. 2016Kirkland, Wa• Purchase material for projects • Purchase supplies for office and shop • Enter projects in database • Maintain project database • Manage employee files • Create and maintain L&I records • Created and maintained employee handbook • Create and update literature • Schedule and coordinate subcontractors • Organize and maintain project files • Assist with payroll • Support bookkeeper • Maintain 401(k) • Coordinate deliveries • Established and maintain the timeclock system • Process new hires • Assemble and distribute contracts • Follow-up on pickup work • Maintain master project schedule • Help resolve employee questions and needs • Maintain relationships with vendors • Created job descriptions
Document Control Associate
SNBL USADocument Control Associate
Jan. 2015 - Dec. 2015Everett, WA• Maintain training records • Maintenance and distribution of SOPs • Maintain Master Schedule • Maintain curricula vitae (CV) • Prepare and submit archive data • Maintain job descriptions • Verify SOP binders • Review and edit SOPs and policies • Maintain standard operating procedures (SOPs) • Maintain and Verify all indexes
Document Control Coordinator
SNBL USADocument Control Coordinator
Jan. 2013 - Dec. 2015Everett, WA• Maintain training records • Maintenance and distribution of SOPs • Maintain Master Schedule • Maintain curricula vitae (CV) • Prepare and submit archive data • Maintain job descriptions • Verify SOP binders • Review and edit SOPs and policies • Maintain standard operating procedures (SOPs) • Maintain and Verify all indexes
Operations Coordinator
New Face Kitchen Systems IncOperations Coordinator
Jan. 2006 - Dec. 2012Woodinville, WA• Schedule Engineering Appointments • Prepare Payroll • Schedule Final Inspections • Assemble and Distribute Contracts • Order Project Specific Materials and Supplies • Follow-up on Pickup Work • Maintain Job Clock System • Process New Hires • Maintain Project Database • Prepare Granite Bids • Maintain Master Project Schedule • Help Resolve Employee Questions and Needs • Schedule & Coordinate Subcontractors • General Office Work • Order Office Supplies • Maintain Relationships with Vendors • Select and Conduct Initial Interview with Applicants • Assistant to the General Manager
Human Resources Assistant
ComcastHuman Resources Assistant
Jan. 2006 - Dec. 2006Everett, Washington, United States- Maintain Corrective Action Log - General Office Work - Offer Approved Candidates Employment - Assist with New Hire Paperwork - Assist with Verifying Payroll - Conduct Assessment Tests for Applicants - Log Medical Leaves of Absence - Help Resolve Employee Questions and Needs - Select and Conduct Initial Interview with Applicants

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Flexible Data Entry Specialist Needed
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