Silena Porch

Documentation Control Specialist - PharMedium

Waukegan, IL 60085

adzjpw@r.postjobfree.com

+1-847-***-****

Motivated, results-oriented Professional with extensive clinical and regulatory knowledge (Good Clinical Practices, Food and Drug Administration, The International Conference on Harmonization and other regulatory requirements), has 22 years of experience in clinical support activities with a broad array of clinical database software programs. Possesses exceptional interpersonal skills to develop and foster working relationships with people across all levels of the organization. Exhibits meticulous attention to detail and has strong organizational skills. Significant experience in the pharmaceutical industry, with proven follow through abilities.

Authorized to work in the US for any employer

Work Experience

Documentation Control Specialist

PharMedium - Lake Forest, IL

May 2018 to April 2020

• Process one or more document types through all procedural steps in accordance with well-defined procedures and guidelines.

• Ensure that pre-established document control requirements (e.g., which document numbering system will be used; how many and which signatures will be required for certain approvals, etc.) are satisfactorily met throughout the duration of the project.

• Receive, track, and monitor documents using standard document management programs to register documents, maintain databases, and produce logs, transmittals, and other reports as required.

• Initiate and reply to routine correspondence related to area of responsibility.

• Work with other staff members as needed to develop and improve services.

• Respond to changing technology environment and participate in decision making activities relating to customers' needs.

• Provide assistance to users in locating electronic information.

• Maintain an accurate file system of all documentation and ensure that the most current revision is maintained and updated on a regular basis.

• Responsible for assisting in general administrative tasks such as file conversions, scan, copy, filing, organizing, collating, mailing, and expediting information as needed.

• Work within precise limits and standards of accuracy. Document Control Specialist

Pinnacle Biologics - Chicago, IL

October 2016 to March 2018

• Created, wrote, and managed records associated with Change Control, Labeling, Supplier Quality, Product Complaints, and CAPA.

• Oversaw the company training system, ensured that all employees were trained to the necessary SOP's.

• Ensured that time-sensitive files were completed within the required timeframe.

• Created and maintained official document files, ensuring that files contain all necessary information. Project Associate

inVentiv Health Clinical - Gurnee, IL

January 2016 to May 2016

• Developed and maintained spreadsheets used to track data and study activities.

• Tracked, logged, and reported on incoming data, study documents, and inVentiv Health Clinical-own materials.

• Verified study documents are reviewed and tracked for completeness and accuracy. Study Document Coordinator

Randstad Pharma - Deerfield, IL

March 2015 to January 2016

(Takeda Pharmaceuticals, Deerfield IL)

• Participated in document control, quality, and compliance; supported the development, review, editing, and management of controlled documents to ensure accuracy and usability.

• Maintained various document management systems to manage label management, product specification, and audit data.

• Maintained orderliness, safety and security of Company Records and processed requests for physical records by users.

Formula & Document Management Systems Coordinator

Info Tree Services - Plymouth, MI

November 2014 to March 2015

(PepsiCo, Barrington IL), • Communicated with outside vendors both domestic and international

• Assisted Company's ingredient vendors with different software programs: Product Vision and Documentum applications related to specification and formula management for data and document submission • Liaison between Product Development and Regulatory teams and vendors for issue resolution

Regulatory Registration Management Coordinator

Collaborative, LLC - Columbia, MD

September 2013 to November 2014

(AbbVie Inc., North Chicago, IL), • Maintained and supported various document management systems and team: registration management and regulatory affairs data with day to day activities including, but not limited: RM data entry, data evaluation, and assessment of processes.

• Supported document change control; ensuring compliance with document management policies, procedures, and best practices and updated global databases. Documentation Gathering Analyst

Experis/NNE - Waukegan, IL

April 2013 to September 2013

(Hospira, Lake Forest, IL), • Maintained various document management systems to manage microbiology, regulatory affairs, and test data.

• Organized all gap assessments for test method related regulatory submissions, analytical and microbiological test methods and stability protocols.

• Organized completed technical gap assessment procedures that required evaluation of documents and comparison of test methods to source documents.

• Prepared documentation of gap assessments and product summary packets for filing electronically or in paper format within client document control systems. Clinical Document Specialist II

Manpower - Waukegan, IL

September 2012 to April 2013

(Abbott/AbbVie, North Chicago, IL)

• Received/retrieved documents from the Clinical Research Specialist, Clinical Study Assistant, and/or Clinical Research Organizations and managed Trial Master File ensuring files were correct, complete, and consistent with Abbott/AbbVie's SOPs and regulatory requirements.

• Created content for Clinical Study Report appendices and provided accurate progress reports on collection of study-specific documentation.

• Ensured scanned documents were available for author/medical writing review per study timelines; managed and archived paper case report forms.

Sr. CMF Associate

Randstad Pharma - Deerfield, IL

June 2012 to September 2012

(Astellas, Northbrook, IL), • Managed electronic and hard copy Trial Master File repositories.

• Established classification, submission, indexing, data entry, filing requirements, and conducted CDEx database searches.

• Participated in auditing, reconciliation, and archiving of the Trial Master File. Clinical Support Coordinator

Ovation Pharmaceuticals, Inc - Deerfield, IL

June 2007 to May 2012

• Maintained Documentum document management systems to manage clinical management and compliance data.

• Coordinated and ensured the timely collection, maintenance, filing, and tracking of study documentation in keeping with established timelines.

• Liaised with Contract Research Organizations in the collection of study-specific documentation necessary for timely drug release and maintained literature reference database. Correspondence Clerk

Randstad Pharma - Deerfield, IL

August 2004 to June 2007

(Takeda Pharmaceuticals, Deerfield, IL)

• Reviewed site and internal documents to ensure quality and accuracy per company standards.

• Assisted with tracking of documents from Takeda Japanese headquarters, Takeda Europe, CROs and investigator sites through completion of internal processes prior to filing.

• Performed quality checks on documents received from Takeda Japanese Headquarters, Takeda Europe, and outside vendors.

• Catalogued and filed essential site and internal documents per company guidelines.

• Compiled and verified documents prior to archival of trial related materials to off-site storage facility and maintained file room.

Education

Associate of Science

College of Lake County - Grayslake, IL

1993

Skills

• Scanning

• Clinical Documentation

• Document Control

• Workday (Less than 1 year)

• LMS (Less than 1 year)

Links

http://linkedin.com/in/silena-porch-97972070

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