DOCUMENTATION CONTROL SPECIALIST/QUALITY SYSTEMS ASSOCIATE
Customer Service & Relations MS Office Suite Performance & Quality Standards Filing & Data Archiving Operations Management Strategic Planning cGMP Trackwise, DataSafe, FileNet Computer Operation
Documentation Control Specialist/Quality Systems Associate May 2013 to CurrentHeartFlow Inc － Redwood City, CA
Support in preparing, drafting, and editing regulatory submissions including technical files, U.S.
filings, and international registrations Maintain and tracked quality metrics Aide in Corrective Actions and Preventative Action Planning and review VOEs for CAPAs Participate in risk management efforts and project/regulatory submission team.
Ensure consistency, completeness, and adherence to Standards for all regulatory submissions not limited to successful 510K De Novo (FDA Clearance Nov 2014), Shonin Submission, and Part 11 Notification.
Coordinate and consult with other departments on content, review, and assembly of regulatory documentation and recommend changes ensuring conformance Aid in researching of compliance of current and new medical device technologies with relevant regional government regulatory agencies Proficient understanding of Medical Device QMS requirements and regulatory requirements Review, author, and approve documents associated change requests to assist in the accuracy and standardization of controlled documents Assist in planning, scheduling, reporting, and tracking of internal audits Successfully manage company's business system, an Electronic Document Management system by Pilgrim Software.
Conduct new hire training sessions for working in a regulated environment and HIPAA Provide support by coordinating, managing, and preparing for California Department of Public Health and International Agency audits.
Assistant Documentation Specialist November 2012 to February 2013GENENTECH － South San Francisco, CA
Retrieve, archive, track, and maintain documents utilizing Trackwise, DataSafe, and FileNet document management systems.
Maintain systems for controlling paper copies of documents and records.
Perform cGMP data entry activities for the receipt and tracking of documents and records.
Provide document administrative support during FDA, internal, and external audits and regulatory inspections Reviewed Manufacturing batch records, QC, and QA controlled documents for accuracy and completeness as requested.
Receptionist/Administrative Assistant March 2012 to June 2012THERMO FISHER SCIENTIFIC － Fremont, CA
Contributes to team effort by accomplishing related results as needed.
Completes operational requirements by scheduling meetings, extensive use of Outlook; expediting work results.
Resolves administrative problems by coordinating preparation of conference rooms, meetings, and voice calls.
Receive and screen visitors and callers; explain procedures and provide information to appropriate staff.
Research Assistant September 2010 to September 2011UC DAVIS DISPARITIES RESEARCH － Davis, CA
Handle and protect confidential and sensitive data with integrity.
Manage data collection projects by meeting paper and electronic mailing deadlines, entering data, transcribing tapes and handwritten notes; learn and use technology to do these tasks more efficiently.
Assist staff in logistical management of the Center, including acquisition of supplies, inventory management, bookkeeping and strategic planning.
Study and screen all the subjects that have registered as study subjects and determine their suitability for the research study that is to be conducted.
Undergraduate Assistant July 2009 to July 2011NUCLEAR MAGNETIC RESONANCE － Davis, CA
Perform general clerical duties to include, but not limited to, bookkeeping, copying, faxing, mailing and filing.
Maintain confidentiality in all aspects of client, staff and agency information.
Conduct research, compile data and prepare papers for consideration and presentation to the Executive Director, staff and Board of Directors.
Coordinate and direct office services, such as records, budget preparation, personnel and housekeeping.
Bachelor of Science (BS) : Psychology Biology, 2011UNIVERSITY OF CALIFORNIA AT DAVIS － Davis, CAPsychology Biology
Certificate, Internal Auditor for ISO13485