WORK EXPERIENCE
Recent Experience 09-2014 / 03-2019
• Manage the routing and release of drawings, control document for the Research & Development team. Create Engineer change requests from markup drawings given by the responsible parties. Expedite incoming PAF to the Engineers.
• Follow up to ensure that all documents (EC, PAF PPAP) have been attend to and released to the appropriate departments, elevate issues needing cross functional or managerial support to resolve matters.
Company Chicago, IL 03-2014 /08-2014
Document Specialist Contractor Planet-Pharma
Maintained organized and efficient document flows by using excellent planning and multitasking skills. Utilized SAP to scan and cleanup project documents.
Issuing Batch Records and Equipment logbooks, QC lab notebook and reconciliation of labels general administrative job and Auditing documents before final closure.
Company Wheeling IL, 2011 /2013
Document Control Clerk.
Transmitted documents, organized revisions and tracked changes. Gathered, reviewed and input Quality Management System, reports each day using Master ISO/TS 16949 Documents Log software. Translate Spanish work instruction.
Managed regulatory requirements and audits support needs by completing and submitting corrective action Plan /5 why update Control Plan, PFMEA.
ITT Bell & Gossett Morton Grove, IL 4-2009 /10-2010
Quality Technician Contractor,
Industrial Motor Pump, Inspecting, identifies issues on incoming or outgoing material for small pumps and perform monthly Inventory.
Morton Grove Pharmaceutical Morton Grove, IL 2007 – 2008
Document Control Coordinator
Maintain master records within SmartDoc program, accordance with Good Manufacturing Procedure and F.D.A standards and methods.
Coordinate issuing batch records and distributed; including transcription of new revisions and current document tracking, routing, documents, communicating and disseminating information.
Dentsply Pharmaceutical Elk Grove Village, IL 2003 – 2006
Quality Assurance,
Effectively interacted with Quality Assurance and incoming material testing area.
Tools of Operation Optical Comparator and caliper, micrometer prior to filling process.
Assigned to perform manual leak test and conducted inspection on leaflets, label, packaging and area/line clearance.
Engaged in the validation department with protocols in (IQ/OQ/PQ) validation of batch records, stability sampling and Standard operating procedure.
PREVIOUS EXPERIENCE
1998-2001 Inventory Clerk, Makita power tool, Mount Prospect Illinois
1996-1997 QA Technician, Courtesy Corp, Buffalo Grove, Illinois
1989-1995 Quality Control, McGaw Labs, Puerto Rico
SKILLS
MS Office Suite, Access, excel
SAP ERP and Solid work
Database Administration
Policy and procedure modification
Quality Assurance
Document Review
