Close
Overlay

MALOU KALUGDAN - San Leandro, California

MALOU KALUGDAN
Send Message
Connect

MALOU's Trophies

Attractive Profile SaleSpider Trophy Image
Premium Member Not Completed SaleSpider Trophy Image

About Malou Kalugdan

MALOU+KALUGDAN
Malou Kalugdan is currently living in San Leandro, California, working as a SR. DOCUMENT CONTROL SPECIALIST / TECHNICAL WRITER and is interested in Biotechnology, Computer Hardware, Consulting, Contracting/Trades, Electronics, Engineering, Internet / IT, Manufacturing, Med. DevicesPharma, Other, Services, Telecommunications.
Not the person you're looking for?
Find more results for MALOU KALUGDAN

Job Title

SR. DOCUMENT CONTROL SPECIALIST / TECHNICAL WRITER

Company Website

https://www.linkedin.com/in/mkalugdan

Location

San Leandro, California

Categories of Interest

Biotechnology, Computer Hardware, Consulting, Contracting/Trades, Electronics, Engineering, Internet / IT, Manufacturing, Med. DevicesPharma, Other, Services, Telecommunications

My Interests

Sr Document Control Specialist, Technical Writer, Engineering Change Analyst, and Documentation Control. If an opportunity comes along my way in the positions of Quality Specialist, Compliance Specialist, Regulatory Specialist, and/or CRA (Clinical Research Associate), I will not hesitate, I will be honored. .

Join Date

MALOU KALUGDAN has joined on Jun 19, 2011

Company Size

1-4

Resume

•Currently seeking a full-time position in Quality within the Medical Device, Pharmaceutical, Biotech, & Medical/Healthcare industry with opportunities & assures professional growth within the company utilizing my knowledge of Document Control, Quality Assurance, Quality Control, Quality System, & Analytic skills.

QUALIFICATIONS
•9 years’ experience in the Medical Device industry as Sr. Document Control Analyst. 5 years’ experience as an Administrative Assistant in the Technical industry. 6 years’ experience in the Network Telecommunications Electronics industry as Sr. Mechanical Assembler/Tester & as Failure Analysis Technician.
•Knowledge of Agile CM/ Administrator, Agile Product Lifecycle Management (PLM), MS Visio, Visual Basic, HTML, Adobe Photoshop/Illustrator/Acrobat/Distiller, XP/Win 7, File Maker Pro, SAP, MS Office, CuteFTP & WinZip. Also, knowledge of calibration, hand tools, machine operation, inventory, rework, sub-assemblies, MRB, daily cycle counts, & data entry, trainer, & line coordinator.
•Strong analytical communication, interpersonal, organizational, & research skills. Quick learner, highly motivated, & dependable. Detail oriented. ESD Certified. A team leader & team player with great leadership ability. Providing years of excellent customer service.

PROFESSIONAL EXPERIENCES
Novartis Vaccines & Diagnostics, Inc., Emeryville, CA The Fountain Group, Tampa, FL
ARCHIVING SPECIALIST Feb 28, 2014 – May 02, 2014 (2 months)
• PROJECT ASSIGNMENT – Archived & Cataloged Study Protocols & Reports into spreadsheets for the Toxicology Dept. & worked closely with PCS Archive Specialist for transfer approval & with Novartis shipping along with External storage facilities for transfer of data.

Novartis Vaccines & Diagnostics, Inc., Emeryville, CA The Fountain Group, Tampa, FL
QC ARCHIVING SPECIALIST Jun 10, 2013 – Dec 18, 2013 (6 months)
• PROJECT ASSIGNMENT – Interim Reports, Protocols, and Archiving & Cataloging of Antigen Seedstocks for the QC Microbiology Department.
• Worked closely with QCM Scientist & Analyst to draft, process, & track protocols & interim stability reports from past recontrol timepoint dates in Atlas 10, enhance organization for Yeast & E Coli Seedstock paper& electronic records in various formats & locations such as DB/shared drives/offsite, and developed naming convention.
• Investigated, queried personnel & systems to locate supporting documents. Created a logical system for filing & cataloging information in standard database (e.g. Access, Excel), transferred knowledge by creating WI, and training QC Management personnel on the system

Optovue, Inc., Fremont, CA Ultimate Staffing, Fremont, CA
ENGINEERING CHANGE ANALYST Aug 27, 2012 – Nov 27, 2012 (3 months)
• Assisted & responsible for maintaining a company-wide Electronic Data Management System (EDMS) of documentations stored in the Windchill (PLM) database ensuring high quality ‘items’ (ECs) are entered accurately.
• Created, analyzed, & processed for new product development, upgrades, accurately routing to the appropriate Change Control Board Members for reviews & approvals, & in compliance with FDA Quality System Requirements Regulation.
• Works effectively with others while providing high-level of assistance/guidance to internal/external customers (interfacing between Engineering, Manufacturing, & Operations) with technical assistance in Change Control procedures in resolving moderately complex issues, provide judgments, & recommendations to manager.

Abbott Diabetes Care, Alameda, CA Capital Staffing
SR. DOCUMENT CONTROL SPECIALIST Oct 01, 2001 – Jul 27, 2010 (8 years 10 months)
• Assisted & responsible for maintaining a company-wide Electronic Data Management System (EDMS) of documentations stored in the Agile Product Lifecycle Management (PLM) database ensuring high quality ‘items’ (ECs/ACs/MCs/DCs/CRs) are entered accurately & maintenance/management of Agile user accounts. Provided Agile support for 500+ users.
• Created, analyzed, & processed for new product development, upgrades, accurately routing to the appropriate Change Control Board Members for reviews & approvals, & in compliance with FDA Quality System Requirements Regulation, ISO9001, & ISO13485 Standards within Agile.
• Works effectively with others while providing high-level of assistance/guidance to internal/external customers (interfacing between Engineering, Manufacturing, Operations, Marketing, etc.) with technical assistance in Change Control procedures/use of Agile software & Doc Specialist I & II in resolving moderately complex issues, provide judgments, & recommendations to manager.
• Assisted in creating, simplified, defined &/or documented forms, work instructions, procedures, & processes for the Doc Control Department. Participated 95% of the conducted clinical studies. Received VP Award Plaque

Nortel Networks, San Ramon, CA
ADMINISTRATIVE ASSISTANT Jan 01, 2001 – Sep 28, 2001 (9 months)
• Processed Telephone Equipment Orders, Completion of Specification, & Quotes for the Engineering Department
• V-Spec Parsing, Manifest download, analyzed data into PAC BELL Database, Cable Tags, Distributed Specifications & Drawings from Engineering Vendor & documented processes. Received Certificate of Appreciation

Pacific Bell (SBC Global Service), San Ramon, CA
ADMINISTRATIVE ASSISTANT Jul 03, 2000 – Oct 20, 2000 (4 months)
• Processed PCRs/PMRs/Org Maintenance/Separation; Processed bills using EVP, primarily SoNo Group & Airborne Express for the DSL/ISLN Development Department
• Processed ID badges & provided Contractor’s & New Hire’s Introduction package
• Ordered new or replaced communication devices for the district & office supplies; Distributed mail, reconciled card statements for the appropriate Technical Directors, & sent to the purchasing card office in St. Louis, MO. Updated phone list & Org charts
• Worked with payroll regarding any discrepancies on employee’s records; followed up with HR regarding new hires, lateral movement, & reorganization. Made travel arrangements. Attended training classes such as Travel arrangements & A/P & A/R

Nortel Networks, Santa Clara, CA
FAILURE ANALYSIS TECH. / ADMIN. ASSISTANT Oct 03, 1994 – Jun 20, 2000 (6 years)
• Used S.A.P. database for inventory, daily cycle counts, material transaction, & parts movements; Used File Maker Pro, Clarify, Dispatch 1, & Microsoft Access to verify the status of materials from customers & wrote up problem stations, scrap materials, & documented MFG procedures when it changes for the R&D Global Repair Service West Department
• Determined & documented reasons for return for TTM’s & FAR’s; called customer support for reasons of return; duplicated failures from the customer’s returns of units. Responsible for data entry (Squidlet), attended daily meetings with management, & supported my line to help get the products out on time. Received Pride Award

EDUCATION
Independence High School, San Jose, CA General Studies (3 years)
Castro Valley Adult & Career Education, Castro Valley, CA Current

INDEPENDENT COURSEWORK
Computer Training–Word 97/00 2002
Aim Computer Training–Word 2000 (Int. & Adv.) 2005
Agile V8 Product Collaboration User Training 2003
Quality System Requirements & Industry Practice 2006
Agile V8.5 PC Administrator 2004
Compliance Media–Documentation Basics 2002-03

SKILLS & EXPERTISE
• 21 CFR Part 11 (Electronic Records & Signatures)
• Adobe
• Administrative Change (AC)
• Agile Testing/Validating
• Agile v9.2.1
• Atlas 10 EDMS (Livelink)
• Change Request (CR)
• ClarityNet
• Compliance
• Creative Writing
• Current Good Mfr. Practices (cGMP)
• Customer Service
• Data Archiving/Entry
• Document Change (DC)
• Doc Format/Image/Review
• Electronic Data Mgmt. System (EDMS)
• File Maker Pro
• Engineering Change Order (ECO)
• Manufacturing Change Order (MCO)
• General Office Duties
• ISO 13485 Quality Manual
• Lotus Notes
• MS Office Ste. 2003/2007/2010
• Microsoft Outlook
• One-on-one Training
• Online Databases
• Process Improvement
• Process Management
• Productivity Software
• Quality Assurance
• Quality Control
• Quality Management
• Quality Systems Requirements. (QSR)
• Records Management
• Regulatory Affairs Requirements
• Service Access Point (SAP)
• Software Installation
• Software Testing /Validation
• Standard Operating (SOP)
• Storage Devices
• Teaching/Mentoring
• Team Player
• Technical Documentation
• Technical Projects
• U.S. FDA Regulations
• User Experience
• Windows XP Pro / 7
REFERENCE Available Upon Request

Quick Profile Summary

MALOU KALUGDAN
Name: MALOU KALUGDAN
Link: http://www.salespider.com/p-10128913/malou-kalugdan
Location: San Leandro,California,United States
Job Title: SR. DOCUMENT CONTROL SPECIALIST / TECHNICAL WRITER

Explore using SaleSpider

Businesses You May Be Interested In

 Business Picture
 Business Picture
 Business Picture
 Business Picture

Other SR. DOCUMENT CONTROL SPECIALIST / TECHNICAL WRITERs from California

 Business Picture
 Business Picture
 Business Picture
 Business Picture

Malou Kalugdan’s Business Connections

Find more information on the Company

Share This Profile

Member Spotlight

bev page Icon
Bev Page
Tour And Travel Planners
Travel Services

Business Spotlight

Union American Roofing Icon
Union American Roofing
Http://www.unionamericanroofing.net
Who Viewed This Page
458376 views
Last Seen
Thursday August 11, 2016
Top Cities
Delhi 1.7%
Toronto 1.17%
Bangalore 1.1%
Top Browser
Chrome Chrome51.56%
Iphone16.42%
Firefox Firefox14.07%
OS Expand
Windows
42.06%
Android
27.51%
Iphone
16.91%
Device Expand
Desktop
50.37%
Mobile
43.63%
Tablet
5.99%
Language Expand
En-US
64.76%
En-us
17.89%
En-GB
2.84%
spacer pixel