Kalpana Vira

(***) *** – **** acy2hp@r.postjobfree.com

Profile:

Seeking an opportunity as an ECO Change/PLM Analyst and Document Control Specialist to utilize my skills and experience.

Skills:

Ability to lead and effectively influence cross-functional teams using excellent team building and customer service skills.

Outstanding team player, work well within a team environment, independently, or with minimum supervision.

Handle multiple projects in a creative, resourceful, and energetic way.

Fast leaner and excellent trainer.

Extremely efficient in Excel (Macros & VLookup), MS Word, PowerPoint, Visio, Outlook, Lotus Notes, Adobe Acrobat writer, QAD, LMS, AutoCAD, TrackWise, Windchill, SAP, and Agile, MacroV

Professional Experience:

Thermo Fisher Scientific, Pleasanton, CA 01/2017-Continue

Sr. QC Technician

Processing and releasing company’s documents through Agile and SAP software.

Performing production Batch Record review, product release, and investigate discrepancies.

Addressing document issues with production supervisors, quality management, and other appropriate groups.

Monitoring document adherence to quality and good documentation practices standards, report associated metrics and recommend batch record improvements per spot-check audits.

Providing guidance and training to manufacturing and other functions in implementing good documentation practices; assist in setting site policies for GDP.

Thermo Fisher Scientific, San Jose, CA 06/2016-11/2016

Compliance Analyst (Consulting)

Prepared guidelines for China RoHS and EU RoHS to determine any or none exceptions.

Prepared training materials for China RoHS to train employees.

Created spreadsheet with thousands of parts with itemize grouping and created summary.

Collected data from a database and created spread sheet to show product lists, product site, and supplier contacts.

Coordinated with RoHS labels implementation on products which deadline was on July 1st 2016.

Stryker, Fremont, CA 04/2016-05/2016

Document Control Coordinator (Consulting)

Processes, stores and distributes controlled quality system documents using a combination of conventional paper-based and electronic Windchill database methods.

Involve in ongoing projects, and the ability to push approvers and complete tasks to meet aggressive timelines.

Abbott Medical Optics, Milpitas, CA 09/2000 – 08/2015

Inventory Controller, Sr. Change Analyst/Sr. PLM Analyst/Document Control

Managed nonconforming material parts from Incoming Quality Assurance (IQA) or the manufacturing floor.

Transacted in a materials management system (SAP) from originating location to predefined location depending on review and disposition of parts by a quality engineer.

Own and managed new/exist product’s ECOs with in Agile/SAP database system. This includes reviewing contents for completeness and accuracy, routing to CCB members, monitoring and analyzing the approval cycle in timely manner and releasing, drafting through implementation process.

Created and updated Bill of Materials (BOM), Engineering Change Notice (ECN), Manufacturing Change Order (MCO), Deviations.

Worked closely with Component Engineers for RoHs parts and processed Changed Orders.

Verified, updated, and monitored all parts pushed through the Agile Interface to the SAP/ERP system.

Changed the process to eliminate Change Orders and shortened the process of Peer Reviews and Quality Systems Procedures.

Compared and read Engineering drawings/spec sheets vs. redline drawings/spec sheets.

Created queries and created daily, monthly, and quarterly reports from SAP/Agile for submission to upper levels and other departments.

Established complete Document Control center as per ISO and FDA regulation.

Complied with Quality Systems procedures to ensure compliance with FDA QS Regulations, ISO 13485, Medical Device Directive, Canadian Medical Device Regulations.

Interacted with on-site and FDA/TÜV during audits concerning Document Control and Quality records.

Agile Administrator – responsibilities includes new user introduction / password assignment / general maintenance. Train new Agile PLM users.

Education:

Agile Administrator Certification 10/ 2003

Certification in Medical Assistance 10/1998

Ohlone College, Fremont, CA

SNDT College, Mumbai, India 03/1987

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