Jennifer Carlsen Email and Phone Number

• Execute and oversee GxP document management activities within the ElevateBio EDMS. • Issuance and reconciliation of controlled documents for use including logbooks, laboratory notebooks, Batch Records and Technical Data Reports (TDRs). • Support the archiving and retention of executed GxP records both paper and electronic. Work with cross functional groups to ensure compliance to ElevateBio retention and archiving requirements. • Create and/or review SOPs, material or other documentation related to the management of controlled document issuing, retention and archiving. • Assist in the generation of accurate training documentation and submission for record keeping. • Act as a subject matter expert (SME) for the ElevateBio eLMS and provides support for users. • Support continuous improvement projects for the ElevateBio GxP Training and Document Control processes.• Support client audits and regulatory inspection readiness activities• Promote a Quality Culture by supporting innovation, teamwork and efficiency within the organization

• Support Veeva Vault Quality GxP Electronic Documentation Management System (EDMS)• Work directly with the QA department and cecross functional teams to revise, issue and track controlled documents and records to meet timelines. Provide status updates and reminders when necessary.• Support archiving of documentation.• Set-up archiving room and create inventory of records.• Support the GxP Training Program• Support Training record Management within the Learning Management System.• Review and archiving of all Training and Onboarding Records.

• Assisted company in conversion to electronic documentation system by inventorying, scanning, and uploading all electronic files to cloud based documentation system.• Prepared, packaged and transferred documentation to Iron Mountain for off-site storage.

Onboarding of new employees• Create training plans based on employee role• Electronically assign SOPs and document training courses utilizing SumTotal GEL Learning, Magic, and MyWorkshop electronic document systems.• Prepare Employee training folders• Perform QA review of Training Qualification Forms, Clean Room records and Logbooks• Perform all documentation retention and archiving duties onsite and externally through Iron Mountain• Initiate and own document control deviations using Veeva Vault QMS

QA SpecialistLakePharmaMay 2020-Aug 2020• Created and Processed Material Specifications and performed QA release of raw materials.• QA Review of solution and processing batch records, QC Data and QA Batch Release.• Attended Production and Buffer meetings as QA representative and reported back to manager.• Performed Line Clearance and change over procedures in Manufacturing Suites.• Performed QA review of calibration records.• Created and revised QA SOPs and Work Instructions and assisted in revising Master Validation Plan.QA Documentation Specialist LakePharmaMay 2019-May 2020• Primary Document coordinator for paper-based system.• Primary in creating and implementing custom Electronic Document Management System (EDMS). • Worked with IT to implement EDMS. • Completed document review for EDMS rollout (Checking attributes, files, etc.). • Primary in creating EDMS workflow, creating user and QA processing instructions, ensuring processes aligned with paper procedures/electronic document regulations. •Trained all associates in all document control processes and new EDMS procedures.• Developed an inventory system for all archived records. Implemented the use of out cards so documents are tracked more consistently.• Initiated the use of formatted templates to streamline the formatting process for both users and doc control personnel.• Assisted in Client Audits – retrieving and reconciling records

• Document control functions as coordinator for SmartSolve electronic document management system. o Format documents, process change requests, change orders and route documents for review and approval.o Support multi-departments, including but not limited to Validation, Manufacturing, and Clinical.• Write and revise applicable SOP & WI documents.• Create, revise and maintain document templates.• Assisted with document management system administrative duties, system troubleshooting, and preparing of monthly metrics.o Created and maintained users, document types and attributes and submit help tickets within electronic document management system.• Assisted in document management process improvement.• Revised and executed test scripts to validate electronic document management system during system upgrades.• Performed inventory, archival and document recall of all incoming records; prepared and recalled records to and from external archiving site.• Assisted in training sessions to ensure document system compliance. • Assisted in war room during regulatory audits retrieving and reconciling documentation.• Updated Controlled Binder Site, assisted in issuing logbooks.• MPR & Label issuance.• Review and approval of manufacturing solution batch records.

• Lead Operator in preparation of processing buffers & assisted in training of new employees.• Created the Chemical Tracking SOP to document material movement and chemical usage.• Document Coordinator for all manufacturing records to ensure processing timelines are met.• Assisted in development of manufacturing training program; creation of roles, training modules and assessments to improve training program.• CIP of processing equipment, preparation/operation of Direct Flow Filtration, HTST Pasteurizer & UFDF systems within Pilot Plant/Clarification Facility.• Operated complex systems and equipment in strict accordance with current GMP's, SOP's, and safety guidelines.• Utilized SmartSolve, Compass & Pilgrim for Documentation/Training Coordinator responsibilities (track, route, format MFG documents and employee training records).

• CIP of process equipment and preparation/operation of Microfiltration and Chromatography systems within a large scale cGMP protein purification suite. • Utilized SAP, TrackWise, & LIMS for Quality Assurance purposes, Deviation investigations & laboratory sample management.