P.O. Box ****, Newark, CA ***** Cell: 510-***-**** or 510-***-**** Email: ac2dku@r.postjobfree.com

Arleen V. Pena

Summary

Extensive experience as an Executive Administrator for over 20 years. Current industry background in Pharmaceutical and Medical Devices, Biopharmaceutical & Engineering Services in Semi-conductor & BioTechnology. Educated in the BioTechnology and BioManufacturing, Medical Admin Assistant, Healthcare with a Bachelor of Arts Degree in Social Sciences, Majored in Psychology and Minored in Sociology. Bill of Material (BOM) creation and Change Management of the Product Lifecycle analyst. Part and BOM creation, change management, effectivity dates and material disposition. Best practices and internal business processes with relation to change management and general PLM functions. Detail oriented with strong record-keeping management, Manufacturing, Supply Chain and Human Resources generalist. Proficient in MicroSoftOffice Word, Excel, Powerpoint and Access. Google aps functions and documentation. Inventory Control & Batch Records Release to Finished Goods, MSDS, MDS,RoHs Administrator, FDA & Third Party internal audit preparation, back room audit preparation, ISO 13845, ISO 9001, Epicor and IQS/AQM dBase Science, Analytics and Management, Change & Product Lifecycle Management, NCRs, CAPA, Deviation Reports data mining, analysis & review, Arena PLM, Calibration and Equipment maintenance, Calman, Blue Mountain RAM, SAP, TrackWise, PDM Analyst, cGMP, GMP

Skills

Project Management, Bill of Material (BOM) configuration analyst and Change Management of the Product Lifecycle Management. Microsoft Office2010 - Word/Excel/PowerPoint, Outlook, Google Aps: Gmail/Gsheets/Gslides/Gdocs, Access, Adobe Photoshop/Illustrator 9.0, Solid Works, Visio, Visual, Citrix ERP Transfer & Implementation, Change Management, Agile 9.5X, Master Control, LIMS, Epicor and I,QS/AQM dBase Management, Arena PLM, PDM, CalMan, Blue Mountain RAM, CGMP, GMP, Adobe Acrobat Reader, iCloud, SAP, Peregrine on SalesForce, TrackWise, WiseTrack

Work Experience

06/16 – 05/17 Genentech, Inc, So San Francisco (on contract assignment for NESC Staffing)

Maintenance Data Specialist Duties: Collaborating closely with the Drug Substance and Products Process Equipment Maintenance Execution Facilities group. Responsible for initiating and managing change records related to Maintenance SOP generation and revisions. In addition Special projects, i.e. Maintenance Calibration Intervals Extension, various responsibilities and tasks associated with maintenance execution process improvements and corrective actions such as document revisions, report generation, research, analytics and data science mining. Skill sets in Quality Records completion, Change Record initiation, Calibration, Instrumentation and Master Data. Systems experienced in Discrepancy Management System, Calibration Management / Systems, GMP Records, Change Control Systems, CalMan, Blue Mountain RAM, SAP, TrackWise

10/15 – 03/16 CalTrain Planning and Modernization Program, San Mateo (on temporary assignment for Search Pros Staffing, Inc.)

Records Administrator Job duties include assistance with Contracts and Procurement for the preparation and processing of Invitations for Bids (IFBs), Requests for Proposals (RFPs), Requests for Quotations (RFQs), and Purchase Orders for the procurement of goods, professional and other services, and public works for SamTrans and the Peninsula Corridor Joint Powers Board (PCJPB).Provides guidance and administration of a wide variety of contracts including on-call contracts requiring work directive releases, special project creating and building an electronic library for CMP in preparation for FTA Audit, Adobe Acrobat Reader

10/14 – 05/15 Boston Scientific Corp, Fremont (on contract for TIPS Consulting, Inc.)

QA Calibrations Decommissioning Management Job duties include the daily activities of facilitating Exit Calibration Decommissioning Project Management instrumentation and equipment for the Retirement Plan of product lines in Extrusion, Stents, OptiCross (8French Line), PZT Lab to ensure conformance and compliance to calibration standards, as production build transferring to Costa Rica in 3Q15, PDM processing DCOs for released transfer of calibrated items, NCRs, Review of CofA for Deviations, Adobe Acrobat Reader

02/14 – 08/14 Acclarent, Inc, a Johnson & Johnson Company. Menlo Park, CA (on contract for Kelly Services, Inc.)

QA Document Specialist Job duties include the daily activities of facilitating Arena PLM DCO/ECOs Change Management Approvals of document control database and document changes within the ERP system, as well as administrating associated training record requests. Responsible for Systems Administrator for new employee on-boarding associated with the Quality System. Assist in daily Document Control / Change Control Management of the Product Lifecycle, work with Engineering New Product Introductions and Document Product changes, administrate daily Training activities for New Hires. Part creation and approval of required Employee training sets (EMP BOMs) into the system, create and release BOM structures as provided by Engineering and Manufacturing for groupings and structuring, Training Completion Requests, granting access/termination of Quality System database, special project Records Archival Management to DataSafe, Adobe Acrobat Reader

07/13 – 12/13 Complete Genomics, Inc. Mountain View, CA (on temporary assignment for Bayside Solutions, Inc.)

QA Assistant for a whole human genomic sequencing and bioinformatics/ services for medical, agricultural and environmental applications. Review, set-up and update of QA employee training and equipment databases, review and revision of Production and QA controlled documentation, ie Calibrations & Equipment set-up, clean-up, new data entry and maintenance and consistencies in Epicor and IQS/AQM dBases, WIKI Confluence, Adobe Acrobat Reader

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09/12 – 11/12 Bayer Healthcare Pharma, Inc. Emeryville, CA (on temporary assignment for The Fountain Group)

Doc Specialist for a subsidiary of Bayer AG involved in three major areas of health care, prescription medications, biological products and biotechnology. Special Project for the overall maintenance of related records, performs archival and retrieval of records; maintains related areas in an inspection-ready state, LIMS, electronic library maintenance, Adobe Acrobat Reader

05/12 – 06/12 Medivation, Inc. San Francisco CA (on temporary assignment for Target CW)

QA Specialist for a biopharmaceutical company focused on the rapid development of novel therapies to treat critically ill patients. Cleanup dbase records for Master Vendor/ Incident Reports/Component Names/CAPA, Audit Lists prep, documents/data entry fields for audit preparation, Sharepoint – Excel/tables, Master Control, Supplier Audit Team/AVL, employee training records, filing system

06/11 – 10/11 Ultra Clean Technology, Hayward CA (on contract for West Valley Engineering Group)

Document Control Coordinator for ECO/MCOs, i.e. drawings, BOM creation and management, Parts lists specs. Maintenance of Master drawing and DHFs, including schematic, tech drawings & other doc records. Special projects of quality standards & good manufacturing practices (GMP); ISO-9000 standards regulations, procedural guidelines maintenance. Provides doc control svcs-testing models and scenarios. Software: Agile 9.5X Project Management, Citrix, Adobe Acrobat Reader

04/10 – 10/10 Thermo Fisher Scientific, Fremont, CA (on contract for ATR Int’l)

Document Technician to assist Manufacturing Product Planning with Indy Rebranding and CDD Rebranding, Regulatory Labeling Special Project-electronic. Issue Part numbers through Agile and Purchasing. Artwork Review Board review for Regulatory, Marketing, R&D, QC, etc. approvals, corroborated with Graphics Specialist to meet ARB requirement artwork, QAD/BOM Redlines, MRF Inventory. PCO Initiator-Prepares and routes PCO in the document management system. Update and maintain Master Spreadsheet daily tracking PCO approvals and release. Software: Agile 8.3 Project Management, Master Control, QAD, Adobe Acrobat

09/09 – 12/09 Argo Medical aka Omniflo, Inc. a Transvivo Company, Richmond, CA

QA Specialist for a start-up, cGMP controlled documents, FDA Quality System. Regulatory Compliance to Quality Policies and SOPs, RPT/VAL, special projects and dbase management, Approved Supplier List management, COR/SOP/SWI/Protocols processing/revisions, internet research and analysis, CAPA investigations. Implemented tracking and logging systems-CD Software Releases, Document Requests, Software Offsite Archival, Ops Manual Issues, Employee Training Records, IQC processing of goods

05/08 – 09/09 Inverness Medical Innovations, Cholestech aka Alere, Inc, Hayward, CA (on contract Kelly Services, Inc.)

QA Lab Tech & Doc Control to support Quality Engineering and Document Control, lab responsibilities. Responsibilities include batch record review & release to finished goods, basic laboratory tasks, provides QA/QE support, data entry, supplier dbase management for QSL/ASL’s, ECO/DCN processing, FDA & Third Party Audit doc & archive prep, Inv Control Plan of supplies, and Cert of Destruction. S/W: Master Control, NCRs, CAPA, Deviation Reports data analysis & review, Calibration Library maintenance, CoA Cert review at IQC, processing IQC forms to release product, Adobe Acrobat Reader

08/06 - 04/07 Synaptics, Inc., Santa Clara, CA (onsite contract for DSI, Inc.)

Document Control for a high tech PCB, NPI Manufacturing Engineering environment.

Responsible for daily FTP to Contract Mfg & HKG, Agile Express PDX files. Released daily BOM ECO/DCO processing change orders & verify successful FTP into the ERP system in Avante’s HK/SC dbase. Oracle test models and scenarios, RoHS transition to HK, RoHS Compliance Administrator for MSDS/MDD/MDS. Software: Agile 8.3 Project Management

Education

BioManufacturing Certificate – Laney College, Oakland, CA, 6/09

Biotechnology Certificate - Regional Technical Training Center Oakland, CA, 6/08

BioManufacturing Certificate - Laney College, Oakland, CA 6/08

RCFE Administrator Certified/State Licensed – Community Education, LLC, Stockton, CA, 9/07

Medical Administrative Assistant Diploma – Bryman aka Everest College, Hayward, CA, 2/04

BA Social Sciences, Major: Psychology/Minor: Sociology – Assumption College, Makati, Philippines, 4/01

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