Summary:
I’m a documentation professional with around 4 years of experience in document control, change orders and change request.
Gained around 2 years of experience working in Thermo Fisher Scientific, Hologic, involved in scanning and uploading all files for QC investigations in the EDMS.
Tracked, approved and processed the change orders and deviation.
Managed and maintained the quality systems like CAPA with the ability to identify problems, find the solution, and make improvements within the EDMS.
Available and willing to work remotely.
Experience with Infowork, QCBD, Master Control, Agile, Share Point, and Concur.
Education:
Associate degree in Business Administration, Business Office Technology - 2017
Cuyamaca College – San Diego, CA
Bachelor degree, Computer Science 2004
Al Mansour University - Baghdad Iraq
Skills:
•Experience in administrative work, translation, and interpretation; excellent multi-tasking, organizational, and communication skills.
•Languages: Bilingual (Arabic & English)
•Computer proficient: Microsoft Office (Word, Excel, Publisher, PowerPoint, Access, Outlook), Adobe, QuickBooks, InDesign, Microsoft Project, and advanced Internet research skills, Info work, QCBD, Master Control, Agile.
•Comfortable working on tight deadlines and managing several projects simultaneously.
•EDMS (Electronic Document Management System) – Info Works
Work Experience:
Sanford Burnham Prebys Medical Discovery Institute November 2023 - Present
Research Administrative Coordinator
Supports faculty and lab administrative activities through demonstrated competency in all responsibilities of the entry level Research Administrative Coordinator position and additional responsibilities as described herein.
Prepares and maintains support documentation for grant applications, progress reports, final reports, and other documents for faculty
Establishes priorities and organizes workload to meet or exceed all deadlines.
Develops and maintains calendaring to ensure that Faculty receives adequate information regarding deadlines, to ensure goals and objectives are met.
Serves as administrative liaison with other institute and administrative departments to ensure day-to-day tasks are completed and or followed up on regularly to ensure positive completion.
Maintains file management of publications, financial reports, emails, receipts, invoices, and statements. In addition to general administrative duties; photocopying, filing, mail sorting, preparing correspondence, distributing and maintaining information posted to lab bulletin boards, within the scope of Administrative Services.
Accesses, navigates and utilizes the internet and SBP intranet and library, complete searches and downloading of research papers, white papers, and various scientific journals.
Assists with manuscript submissions and maintenance; ensuring all publications comply or brought to compliance per NIH Public Access Policy.
Coordinates all travel (foreign and domestic) per institute policy and procedures; flights, hotel, conference registrations, ground transportation, and creates travel itineraries.
Liaises with Human Resources and the Office of Education, Training, and International Services regarding lab recruitments per institute policy and procedures.
Performs other duties as assigned to meet institute needs
Hologic May 2023 – Aug 2023
Quality Assurance Specialist/Document Control/Change Analyst (contract)
•Followed standard practices and procedures when analyzing situations or data.
•Exercised good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
•Enforced corporate standards and procedures in accordance with governing guidelines
•Coordinated with change order originators to create, revise or obsolete documentation with the appropriate approvals.
•Processed Engineering Change Orders and ensured proper approvals and validated changes are released into the system.
•Updated and reproduced Engineering, Manufacturing and Quality documentation for the organization.
•Ensured documentation files and history records are accurate and current.
•Tracked and coordinated change order completion, approval, and implementation.
•Generated Agile training materials.
ThermoFisher Biotech (formerly Mesa Biotech) Nov 2021 – Jan 2023
Senior Document Control Administrator
•Assisted the quality and manufacturing teams in batch production activities by providing guidance of quality problems.
•Managed the Change Orders in QCBD (EDMS) (It’s a process within QMS and EDMS Document Control module for updating, revising, obsoleting, or replacing a document which includes users performing subject Matter Expert assessments and following an electronically-controlled approval cycle. Users must sign all significant actions with their password).
•Assessed and approved the Change Orders and Deviations (according to specific matrix)
•Managed the Deviation in the QCBD (EDMS) (it’s Non-Compliance with approved manufacturing, receiving inspection of quality process or procedure)
•Managed and maintained the quality systems like CAPA with the ability to identify problems, find the solution, and make improvements within the EDMS (QCBD and Master Control).
•Managed and coordinated Batch Records, QC data, reports, specifications, SOPs, and forms.
•Assembled capital equipment project documentation for cGMP manufacturing.
•Reviewed all the documents for accuracy.
•Scanned and upload all files for QC investigations in the EDMS (QCBD and Master Control).
•Built and managed customer facing documentation while ensuring accuracy, integrity, and quality.
•Built and edited work instructions (SOPs) that standardized procedures and maintained daily progress reports.
Thermo Fisher Biotech (formerly Mesa Biotech) Apr 2021 – Nov 2021
Assembler
•Assembled parts for Covid -19 test medical device
•Worked in different stations of production line (machine station or manual station) in dry room.
•Used measuring materials like rulers, height gauge, calipers, and pin gauges for inspection.
•Experienced with Geometric Dimensioning & Tolerancing GD&T.
•Read and interpret engineering drawings, blue print, specifications, and industry workmanship standards.
Micro-Mode Product Inc. San Diego, CA Jul 2012 – Oct 2013
Assembler
•Assembling parts to produce connectors used in special purposes.
•Using Measure materials like rulers, height gauge, calipers, and pin gauges for inspection.
•Experience with Geometric Dimensioning & Tolerancing GD&T.
•Read and interpret engineering drawings, blue print, specifications, and industry workmanship standards.
Bechtel National Inc. (US Company) Sep 2004 – Aug 2006
Document Controller
•Performed document control activities at the Baghdad South Power Station during construction of the new combustion turbine power generating facility utilizing Info Works (IW) and Standard Document Numbering System (BINS)
•Processed vendor submittals as well as Bechtel generated documentation
•Provided assistance to office engineers with vendor submittals and Bechtel documents as well as Bechtel applications such as Bechtel University
•Coordinated with sub-contractor (General Electric) by accessing their electronic data base to retrieve engineering submittals and project deliverables.
US Army Corps of Engineers Baghdad, Iraq Nov 2008 – Jul 2009
Real Estate Technician/Executive Assistant
•Determined realty rights and land ownership of property occupied by the coalition forces and prepared documents to return/transfer the property to the Iraqi Government
•Reviewed and translated complex real estate documents, providing in depth analysis in terms of ownership rights and transferability of the land
•Prepared real estate maps and provided resolution of ownership to determine accurate boundary locations.
Alliance for African Assistance - San Diego, CA Jul 2011 – Oct 2011
Volunteer – Secretarial and Administrative Assistant
•The Alliance for African Assistance is a registered non-profit organization that resettles refugees in San Diego County, offering a wide range of services that include economic development, employment services, immigration services, translation and interpretation services and provides a health clinic.
International Rescue Committee - San Diego, CA Aug 2011 – Sep 2011
Volunteer – Graphic Design Internship – Resettlement Department
•Completed a copy of layout for an Arabic version of an education and training manual
•Translated content from English into Arabic
Reference Information: -
Jennifer Vaz
Home: - *******@*******.***
Email (Work): - *****@*******.***
Telephone: 301-***-****
Fatima Hidalgo
E-mail: - ******.*******@**.******-******.***
Cellphone: - 619-***-****
Brendan Balsamo
E-mail: - **************@*****.***
Cellphone: - 949-***-****