Experience

Tanvex Biopharma USA, Inc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Document Control Spelist II

  • Oct 2016 - Present



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Quality Assurance Document Control Specialist II

  • May 2013 - Oct 2016

  •Perform Records Management duties, process new and updated documents using EDMS package and Microsoft. Support FDA and EMA audits and any other audits for Records Management. Responsible for all documents submitted to the QA Vault. Process all SOPs and update as needed. Document Controller duties in EDMS are: pull packet and upload into EDMS. Process assignment new SOPSs. Send Change Request to approvers via Trackwise. Rejected workflow return and format in Trackwise. Contact Change Owner to collaborate on issue and fix them. Quarterly audit SOPs as needed for all departments and change out SOPs in all departments. Use query tools to extract data and create reports as required through EDMS. Perform weekly audit for overdue document (DARs) Document Audit Request. Interact with personnel at all levels with high professionalism. Train department on new audits. Know CGMP regulations and concepts preferred, particularly good documentation practices. Perform daily updates in the vault by labeling and scanning. Box documents for offsite storage and update spreadsheets daily. Inter RFRs into EDMS upon receiving. Update signature card in EDMS. Work close with QC on submitting Lot Disposition and AHRs to Records Management. Perform quarterly 5S Audit in the vault. Ensure all documents are inspection ready a MUST. Show less



Alere Inc.

• United States
• Medical Device
• 700 & Above Employee

• Production Coordinator I for the Chemistry Department

  • Oct 2012 - Apr 2013

  •Perform review of documents C of A’s, MRP, Validations and Non-Conformance Reports. Perform required transactions utilizing the MRP system (JDE) such as Material Transfer transactions, Work Orders Issued and Test Result Enter. Assist team with document authoring and editing using the Change Control system including creation and revision of department related SOPs to support quality processes. Obtain the appropriate approvals, submission and routing. Responsible that all manufacturing documents are completed and moved to QA in a timely manner in accordance with company documented processes and regulatory compliance guidelines. Streamlining and reporting all relevant team metrics. Foster intra and interdepartmental communications by serving as an informational resource for the Department. Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR. Implementation and effectiveness of Alere’s Quality Management System per ISO, FDA and other regulatory agencies. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities. Perform other duties and projects as assigned. Label product in freezers and push on into JDE for production. Show less



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Quality Assurance Document Control Specialist II

  • Jun 2011 - Oct 2012

  •Perform Records Management duties, process new and updated documents using EDMS package and Microsoft. Audit SOPs as needed in all departments and change out SOPs in all departments. Use query tools to extract data and create reports as required through EDMS. Perform weekly follow-ups on overdue document audits (DARs) Document Audit Request. Interact with personnel at all levels with high professionalism. Participate in FDA and EMA audits. Perform Yearly Quality Audits in the vault. Train department on new audits and procedures. Know CGMP regulations and concepts preferred, particularly good documentation practices. Update vault documents daily by labeling, scanned. Inter RFR’s in to EDMS upon receiving. Update signature card in EDMS. Show less



Soft Gel Pharma

• Northridge California

• Quality Assurance Document Specialist

  • Sep 2009 - Dec 2010

  •Maintain employee/payroll records, auditing timekeeping. Procure database, create spreadsheets, and provide reports, entering new hires into the payroll system. Provided training on documentation to other document specialist process document request. Edit documents, draft layouts and coordinate submissions. Participate in audits as needed with controlled documents and adhere to SOPs. •Maintain employee/payroll records, auditing timekeeping. Procure database, create spreadsheets, and provide reports, entering new hires into the payroll system. Provided training on documentation to other document specialist process document request. Edit documents, draft layouts and coordinate submissions. Participate in audits as needed with controlled documents and adhere to SOPs.



Countrywide Home Loan: 09/02 – 11/08

• Westlake Village, California

• Quality Control Corporate Auditor/Collections Specialist

  • Sep 2002 - Nov 2008

  •Quality Control Corporate Auditor for Central Compliance Secondary Marketing with special project to research, develop, review and provide to management to ensure the capability to perform within mandatory Compliance Regulations. Legal Department, Foreclosure Claims, Bankrupt departments and Eviction Services support in all areas Coordinate lockouts with Courts and Sheriff’s then process all summons and complaints for the Attorneys and Courts to maintain legal procedures. Worked both front and backend on the loans to make sure QA. Show less



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Regulatory Affairs, CRIC (Clinical Records International Center), Document Coordinator

  • Jul 1998 - Aug 2000

  •Ensured EAGLE Database and Filter Database (Bar-coded Document Tracking) was within compliance with all regulations, policies, and procedures. Provided customer service for Regulatory Affairs at the DRC front desk. Develop and maintain file room documentation of all drugs being studied on patients. Assess Quality Assurance edits documents and reviews content for completeness, accuracy and correctness of language. Provided Administrative Coordinator Support Scheduled Meetings, scan documents, edit drafts, answer phones. Develop, implement and Edit documents, draft layouts and coordination submissions. Maintained Database, create spreadsheets, great visitors acting as a liaison to strengthen and reinforce the company concept. Provided training on documentation to research, develop and review. Format all QA Validation documents to FDA compliance Show less