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Work Background
ModernaSupervisor Engineering Documentation
Jan. 2022Norwood, Massachusetts, United States• Management in processing document workflow in Veeva and archiving of Facilities and Engineering documentation and drawings for construction and equipment activities. • Formatting and quality check of digital surrogates and metadata of physical records • Management to maintain document information for facility and Engineering documents in Veeva • Process Owner of Facilities and Engineering Document and Drawing Management SOPs • Created and established standard best practices for ETOP generation and approval • Created and established a drawing management program and project tracking tool • Management of CAD team to update for all Moderna P&IDs and drawings internally • Owner of Native file repository and Engineering Document Management SharePoint • Created and implemented a redirect memo program to improve data searching in Veeva • Administrator of P&ID numbers and equipment tag assignment of Facilities Utilities Systems and Equipment
ModernaEngineering Documentation Management
Sep. 2020 - Jan. 2022Norwood, Massachusetts, United States• Management in processing document workflow in Veeva and archiving of Facilities and Engineering documentation and drawings for construction and equipment activities. • Formatting and quality check of digital surrogates and metadata of physical records • Management to maintain document information for facility and Engineering documents in Veeva • Process Owner of Facilities and Engineering Document and Drawing Management SOPs • Created and established standard best practices for ETOP generation and approval • Created and established a drawing management program and project tracking tool • Management of CAD team to update for all Moderna P&IDs and drawings internally • Owner of Native file repository and Engineering Document Management SharePoint • Created and implemented a redirect memo program to improve data searching in Veeva • Administrator of P&ID numbers and equipment tag assignment of Facilities Utilities Systems and Equipment
TakedaArchive Specialist II
Apr. 2018 - Aug. 2020Greater Boston AreaResearch & Nonclinical Scientific Documentation Archives – CRO Management Lead • Process Owner for CRO Management of GxP Level off-site storage, archives recall, specimen archive management (onsite) and regulated destruction. • Oversight and collaboration to implement a validated inventory management system and database work instructions • Managed a team consisting of three contractors while cultivated team/project management skills through a mentorship program • Created and established training program with process maps and templates for consistency and control of the regulated materials • Owner and manager of the GLP off-site archives collections • Owner and creator of a SharePoint site containing project management lists and chain of custody documentation. • Stakeholder for internal audits for FDA and at CROs, as subject matter expert in specimen archiving and chain of custody • Oversight and collaboration to create and execute a record recall program for materials held at CROs • Completed quality actions, opened and closed CAPAs and documented essential information within TrackWise • System subject matter expert to support change controls in information management systems • Managed 4.5 million dollars budget’s forecast, allocations and accruals in Coupa • Led a round table discussion at the 2019 PRIMO (Preclinical Records and Information Management Organization) Board Meeting as a subject matter expert in specimen management and GLP archiving and destruction. • Member of the EHS building safety committee
Shire PharmaceuticalsArchive Specialist
Oct. 2016 - Apr. 2018Lexington, MassachusettsResearch & Nonclinical Scientific Documentation Archives – CRO Management • Maintained strong relationships with CROs and operation leads to efficiently execute contracts to coordinate the approved disposition (i.e. retain, destroy) of materials held onsite facilities and at CROs • Appraisal and processing of acquired and divested non-clinical materials held at CROs to successfully transfer ownership • Administrator in Shire’s program Master Schedule database to maintain accurate archives information • Logistical management, issuance and organization of program codes with a firm understanding of industry pipeline • Collaborated with procurement, legal and quality to renew the MSA with our GLP off-site storage supplier and create contract templates to enforce GLP regulations
Shire PharmaceuticalsLibrary Services Project Assistant- Archives
Sep. 2015 - Oct. 2016Lexington, MassachusettsResearch and Nonclinical Operation - Library Services and Archives • Managed and maintained the onsite collection inventory data list processing of paper records and external electronic media, including materials associated with acquired products • Fulfillment of regulatory submission activities to collect non-clinical supplementary archive information • Formatting and quality check of digital surrogates and metadata of onsite collection
Industrial Economics, Incorporated (IEc)Data Analyst
Jun. 2015 - Aug. 2015Cambridge, Massachusetts, United States• Assigned to analyze, reformatted and categorize word files, images, slide decks and spreadsheets.
Agassiz Baldwin CommunityAdministrative Assistant
Jul. 2014 - Sep. 2014• Collecting and managing essential documents for children’s summer camp registration and relevant records • Managed financial records in Quickbooks
Lesley UniversityLibrary Assistant
Jan. 2014 - Aug. 2015• Provided excellent public service to faculty, staff and students as a research aide • Located, charged and discharged items while maintaining book collection using LC call number system • Contributed to the move of the library collection of over 10,000 books to another location
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