Marisol Jimenez-Santiago
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Professional Profile
Documentation Compliance Technician with more than twenty years of experience in the pharmaceutical industry. Expertise in areas such as data and document management, proofreading, word processing and handling confidential information. Broad knowledge of validation/qualification and regulatory processes. Excellent leadership, time management, change management, organization, teamwork, and interpersonal relations skills. Able to perform very well with minimum or no supervision in high pressure work environments. Strong self-management skills. Advanced knowledge in Microsoft Office (Word, Excel, Power Point), Plateau Learning Management System, Share Point, Trackwise, Midas, and SAP. Fully Bilingual (English and Spanish).
Key Accomplishments
Led Technical Operations Department records management process for off-site retention of documents pertinent to the decommissioned API site.
Supported site implementation of Plateau Learning Management System and administered Technical Operations training curriculums; master curriculums and job positions which included safety; regulatory; compliance and job training requirements.
Created a share point site for all qualifications and validation documents for electronic retrieval by plant personnel.
Created spreadsheets that improved inventory management and facilitated retrieval of information and documents.
Facilitated change control process by centralizing documents both electronically and hard copy for easier retrieval of regulatory information.
Served as liaison for corporate regulatory and external audits providing on a timely basis information requested during audit process.
Supported site implementation of CIMS System accomplishing the close out of 15 open projects before Go-Live.
Excellence Employee 2008
Experience
Pfizer – Barceloneta (Weil Group)
Technical Services Specialist (June/2016 – June/2018):
Responsible for the revision of Master Manufacturing Batch records. Create and define process change request via Trackwise for revision and implementation of Batch records. Ensure batch records comply with cGMP’s and current Standard Operating Procedures. Handle Change Request and Batch Record approval process through all departments (QA, Technical Services, and Manufacturing). Provide training to operators on changes to batch records. Provide evidence of implementation requirements for close out and effectiveness of Batch Record.
Merck & Co
Documentation Compliance Technician (DEC/2003-DEC/2014): Technical Operations Department
Responsible for document control of cleaning and process validation, equipment qualification, change control, Process Safety Library and technical documents of API and Animal Health site. All pertinent documentation was scanned and uploaded into electronic repository. Administered spreadsheets with updated document description/document control number assigned and approval dates. Follow up was given to assure proper handling of procedures governing these documents. Acted as change analyst within the SAP system by creating DIRs in SAP to continue with the flow of ECRs and provide support to personnel regarding the approval process flow via SAP. Generated changes to Bill of Materials and Packaging Component Specifications.
Marisol Jimenez-Santiago
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Assisted in the revision and cancellation of Standard Operating Procedures; Forms and Guidelines related to business and plant processes via electronic document management system. Provided the quality department with annual review information for process changes implemented. This included validation information/implementation dates, and lots impacted. On a weekly basis, reviewed training curriculums and ensured that all department personnel completed 100% of assigned trainings. Updated data of trainings completed and curriculum data. Provided site personnel with information regarding the cleaning and process validation and equipment qualification as well as copies of official documents. Assigned control numbers to documents to maintain a proper tracking system. Supported audits by various agencies such as FDA; EMEA; ANVISA; Safety and corporate audits for both API and Animal Health sites.
Merck & Co
Administrative Support (APR/1996 – DEC/2003): Packaging Technology Department.
Provided support to 5 engineers and 1 Manager. Managed spreadsheets of projects assuring all information related to purchase orders, contractors, equipment and expenses were updated accordingly. Provided support in the implementation of the Capital Management System. Assured all projects were closed and budget met prior to implementation of CIM System. Generated/revised Packaging Component Specification and Bill of Materials and assured these were provided to plant personnel and uploaded into an electronic repository. Scheduled meetings and travel arrangements.
Merck & Co
Administrative Support/Purchasing Expeditor (NOV/1992 – APR/1996): Production Purchasing Department
Provided support as Purchasing Expeditor for 6 plants within the site. Expedite assigned purchase orders to ensure all requirements specified in the purchase order are accomplished regarding supply, timely inspection and on time delivery. Facilitate the timely flow of information and services to and from Suppliers, Site Managers, and plant personnel. Review Purchase Orders for terms and conditions regarding materials procured. Handle any delivery inconsistencies or delays and alert management. Deal directly with vendors to ensure prompt and accurate delivery of goods to the site. Accurately created, updated and maintained material exception report to ensure that all Chemicals/Intermediates and Packaging components would arrive on schedule for all 6 plants. Effectively communicated and reported on a weekly basis material status to corresponding plant personnel and procurement personnel. Worked cross-functionally (suppliers and plant personnel) to ensure that any discrepancies with supplies be resolved to avoid any interruption with production.
Education
IN PROGRESS BBA COMPUTER INFORMATION SYSTEMS
UNIVERSIDAD DEL ESTE (SISTEMA UNIVERSITARIO ANA G. MÉNDEZ)
Secretarial Certification:
Career Center - Yonkers, New York
Training and Certifications
Yellow Belt Training
Plateau Learning Management Training
Human Performance
HTML
Microsoft Expressions Web 4
Document Design
