Sheila Shirinpour
Document Control Specialist Ii @Shockwave Medical
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WORK HISTORY
Document Control Specialist Ii @Shockwave Medical
Santa Clara, CA, US
Reviewing, processing, and releasing DCOs in the Virje Document Change Order system (same as Veeva Vault).Generating non-conforming material records in Quality Applications and ERP System in Oracle.Reviewing SOPs and WIs for the accuracy and completion prior recording in Quality Management System.Maintaining weekly metrics reports for DCO\'s working process. Collaborating with the production team to identify and resolve quality issues in labelling and updating the records.Creating Change Order in Oracle portal and updating the status of created items for PNs and LBLs. Working with SolidWorks/CAD and Excel spreadsheets to finalize engineering documents for TLs and PNs.Communicating with the vendors for the Transmittal Documents.Supporting and managing Document Control requests for Admin Change via Manage Engine portal.Communicating effectively with the vendors on updating or releasing products. Check revised documents and complete change orders to assure the highest level of accuracy and conformance with the approved format and standards. Manage DocuSign documents in the SharePoint.
EDUCATION
Augsburg University
Bachelor of Arts (BA), International Business
Rochester Community and Technical College
Associate of Arts (A.A.), Business Administration and Management, General
SKILLS
ABOUT SHEILA SHIRINPOUR
Detail-oriented Quality professional with a solid background in the pharmaceutical and biotechnology sectors. Experienced in coordinating audits, managing document control, ensuring compliance, and performing quality assurance checks. Skilled in maintaining documentation, facilitating cross-functional collaboration, and driving operational excellence. Proficient in Veeva Vault, SharePoint, and quality control tools. Looking to contribute my expertise to a dynamic team focused on achieving high standards and continuous improvement.
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