Barbara Singh

650-***-**** ad4ofi@r.postjobfree.com www.linkedin.com/in/bfsingh1206 Milpitas, California 95035

Summary

●Highly accomplished, detail-oriented results-driven program manager with 10+ years of experience in business analysis and provided early workflow (process) mapping for content deliverable.

●Labelling experience (EU MDR standards): reviewing final artwork, rebranding artwork, and illustrating final label artwork for medical devices.

●Adept at collaborating with cross-functional global, and technical teams to meet aggressive project deadlines, and manage documentation lifecycles from concept through “end of life.”

Technical Proficiency

●Product Lifecycle Management: Agile, Veeva Vault, WindChill, Arena, Master Control, Salesforce Propel, SharePoint

●VISIO Pro, SAP SC/POs, Blue Mountain Regulatory Asset Manager (RAM), Access, Documentum (Oracle DB), Acrobat Image Solutions, (ISI) Toolbox Pharma Edition, Seagull Scientific Bartender

●Proficient: MS Office Suite, Adobe Creative Suite (In Design, Acrobat, Illustrator), FrameMaker, Smart Sheets

●Functional Expertise: QMS Document Control (ISO 13485/21 CFR Part 11/21 CFR 820), Regulatory requirements for labelling artwork including, but not limited to, PLR requirements (21 CFR 201.56 and 201.57)

●Technical Writing/Editing

Education

●University of Santa Cruz (UCSC) Extension Courses - Certificate, Project Management Courses / Web Page Design

●College of San Mateo - Courses to enhance technical and software proficiency for career advancement.

●Learn It – Certified Project Management course

●San Jose State University - BA Art/Technical Arts

Professional Summary

Gilead Sciences, CA (Tekwissen Group) January – March 2024

QA Documentations Specialist I (Contractor)

●Daily tool usage: GVault (Veeva Vault), MS Word and Adobe Acrobat

●Uploaded and routed redlined Shipping & Assembly labels using GVault for PCM approvals

●Verified approved supplier lists (ASL) BOM’s and assembly part numbers using PLM Agile

ICU Medical, San Clemente, CA (Spectraforce) January - May 2023

Labelling Specialist (Contractor)

●Reference style guides to proof labels and ensure all formatting was captured. Update current EDU/MDR symbols on labels

●Implemented redlines using InDesign, Illustrator, Publisher, MS Word and Adobe Acrobat

●Redlined and performed final check for DFUs, IFUs and Booklet country translations

Galvanize, Pomona, CA (EG Science) October - November 2022

Document Control Specialist (Contractor)

●Daily tool usage: SharePoint, MS Word, Acrobat, Slack

●Managed documents and records through Arena’s approval workflow

●Per R&D Engineering Department applied redlines to SOPs, and Work Instructions

Atara Biotherapeutics, Thousand Oaks, CA (Codeforce 360) January - June 2022

Document Control Specialist (Contractor)

●Daily tool usage: Veeva Vault, DropBox, SharePoint, and Adobe Sign-In programs

●Verify hard copy e-records matched archival repository in Veeva Vault

●Verify the QMS requirements for archiving Deviations, CAPA, Change Control, Audits, Batch Records, Supply Chain reports aligned with Veeva Vault corporate standards. Uploaded to SharePoint Index for global access

Valencia Technologies, Valencia, CA November 2021 - January 2022

Documentation Specialist (Contractor)

●Daily tool usage: Veeva Vault, SharePoint, Master Control and Adobe Sign-In programs

●Upload and manage the approval process for Product/Manufacturing/Regulatory/Supply Change teams e-docs (i.e., hardware parts/software releases, SOPs, Work Instructions)

●Uploaded and verified Training Documents were signed and dated before uploading to Master Control

Advanced Bionics LLC, Valencia, CA) (Adroix Corp) July - October 2021

Labelling Specialist (Contractor)

●Effectively reviewed and verified rebranded outsource labels, UGs and UIs followed EU MDR standards

●Maintain chain of custody for controlled documents submitted to country “owner” managers

●AB LLC Hearing Aids and products distributed worldwide.

Abbott Labs, Sylmar, CA (Prokatchers) November 2020 - June 2021

Labelling Specialist/Print Coordinator (Contractor)

●Abbott acquired St. Jude’s Pacemaker Device: Rebranding Project: CD covers, pouches, shipping boxes. Adhere to Abbott’s labelling requirements and referenced EU MDR standards

●Initiated approval workflow in PLM WindChill to release rebranded labels

●Coordinated and performed standard Black and White “Print Check” before final print

●Adhere to Part 820 Subpart D and Subpart K Labelling and Packaging Control Sec 820.120 standards

Cytek Biosciences, Fremont, CA August 2020 - October 2020

Document Control Specialist (Contractor)

●Processed the Quality Documents and Training Records to follow cGMP and Regulatory requirements

●Final review of batch files and found non-conformance practices with signing and dating batch files. Reviewed batch records and MFG traveller records before the audit approval date for consistency. (Subpart L- Sec. 820.140, and Sec. 820.160)

●Working knowledge of 21 CFR Part 820 QSR

Xencor Inc., Monrovia, CA (Ascent) February - May 2020

QA Document Control (Contractor)

●Reviewed and verified batch record templates, filenames and DS & DP reports were included and archived per (Sec. 820.5 Quality System Subpart D-Document Controls Sec.820.40)

●Uploaded scanned document forms, and audit certificates into Veeva Vault

●Collaborated effectively with QA sites located in Monrovia and San Diego

Tata Consultancy Services, Santa Ana, CA August 2018 - February 2020

Program Manager

●Program Manager for a global medical supply company in Santa Ana, California to coordinate the rebranding of post-production manufacturing documents. Trained a three-person offshore team, in Kolkata, India to execute the rebranding of 7,000+ documents and execute approval and release documents in PLM Agile

●Collaborated with Santa Ana IT and Kolkata IT teams, to mirror key stakeholder’s laptop and software configurations for offshore team

●Initiated a three-month training log to track team’s Agile training progress

●Ensured Manufacturing Change Order (MCO) followed rebranding standards to update the required docs.

●Implemented a filename process to track released documents on the Sharepoint: “xxx.Rebranded”, “xxx.Redline”, “xxx.Roadblock”, “xxx.Redirected”, “xxx.Obsoleted”

●As challenges were resolved, offsite/onsite teams successfully completed the project on schedule.

Freelancer: Template Services - D. Davis RN BSN Clinical Trainer 2015 - 2016

●Created multiple Informed Consent Forms, Study Protocols, Clinical Trials, PowerPoint and SOP templates (QA Audit Plans)

Roche, Mountain View, CA January 2016 - August 2018

Sr. Documentation Specialist (Permanent)

●Key liaison on cross-functional projects to collaborate with project/program managers, business analysts, engineers, to ensure documentation was captured, processed, and archived

●As part of the (Tucson/Mt. View), Quality Department coordinated the preparation for notified body audits, document review audits, supplier audits, license certifications, and instructed employees on GDPs

●Liaison Record Retention Coordinator provided instructions and training for bi-annual company-wide record disposal of CDs, USBs, photos and appropriately disposed of damaged calibrated equipment

●Liaison Training Coordinator ensure all training records were compliant and verified by managers for audits

●Responsible for editing customer instruction guides (IG) and submitting translations (10 languages) i.e., field service guides, pamphlets, and shipping instructions

●Performed pre-audit document reviews: tool calibration records, released DHRs, BOMs/ TDs

●Initiated the setup for the Document Control Vault to mirror Tucson, Arizona headquarters for Clinical, Regulatory, Imaging slides, Batch Records, Log Notebooks, Calibrated Equipment, and archived binders

●Initiated and migrated required records to Blue Mountain Regulatory Asset Manager

Roche, Mountain View, CA Permanent Hire, November 2011 – December 2016

Sr. Change Analyst

●Provided PLM Agile training for new employees to upload TDs, COs, SOPs, WIs, new and revised parts through the Agile PLM release and approval workflow

●Collaborated with IT/Agile administration team in Tucson to lead the migration of 6,000 original QMS paper documents, (i.e., DCOs, BOMs, WIs, SOPs, Training/Calibrate Instruments Records)

BioImagene, Mountain View, CA February 2010 - November 2011

Sr. Documentation Specialist (Contractor)

●Initially the DCO’s were processed as paper-approved documents. Prepared all QMS documentation to be transitioned to Oracle PLM Agile

●Coordinated and managed an updated series of multi-language using FrameMaker, User Guides, and Installation Manuals for medical device global release

●Assisted the Regulatory team with preparation and assembling 510(K) and FDA Response Letters

●Received SAP training to submit POs for upcoming Notifying Bodies (NB) audits and procure the goods and services for the Quality Department

Loral Space System, Mt. View (Aerotek Technical) December 2009 - May 2010

●Incorporated (ECOs) for Bus Electronic procedure before routing for approval cycle

Gilead Sciences, Foster City (Aerotek Technical) October 2007 - November 2009

Business Analyst

●Collaborated effectively with the Business IT Process team to migrate acquired documents to Documentum

●Verified test plans successfully imported scanned documents

Regulatory Operations-Archivist (Aerotek Technical)

●Responsible for maintaining hard copies and uploading electronic controlled archives into Regulatory Database

●Per Gilead’s archiving standards, followed record retention requirements, for on-site and off-site storage

Neurogesx, San Carlos (Aerotek Technical) February - August 2006

Regulatory Publisher

●Assisted Regulatory Team to assemble content for the Marketing Authorization Application (MAA) submission

●Designed a "how to" style sheet for future Clinical Study Report (CSRs)

iScience, Menlo Park (Aerotek Technical-Permanent) January - October 2005

Documentation Specialist/IQA Inspector

●Inspected First Article hardware components using attribute sampling plans

●Created a Work Instruction (WI) template for MFG production step-by-step, assembly instructions

●Supported the Regulatory team with formatting, and proofing the following documents for submission Pre-market 510(k), Technical File, and CE Mark

Rigel Corporation, South San Francisco (Aerotek Technical) March – December 2003

Document Specialist

●Incorporated industry standards for editing non-clinical documentation for overall structure, content clarity, scientific notations, parenthetical citations, and footnotes

●Supported the Regulatory team with graphic and template development for FDA projects

Omnicell Inc., Palo Alto, CA January - February 2003

Hardware Technical Writer (Permanent Role)

●Designed Field Service Reference online tool: i.e. illustrations, assemble photos to align with MFG hardware instructions i.e. OmniScan barcode/OmniSurgical Doors & Printer unit

●Initiated an e-catalogue, reducing 40% order errors and ensured version control documents were included

Fineline Graphics Business Owner and Marketing Promoter

●Consultant Designer for Silicon Valley Businesses - Corporate Logos, Technical Writer/Word Template Designer, FrameMaker, Adobe Illustrator

Atari R&D Coin-op Division, Sunnyvale, CA - Pinball Designer, Video Animator, Graphic Illustrator

●Pinball Designer 1980-1981, Computer Animator 1982-1985: Led animator for Liberator, Crystal Castle, Weather Wars, Wiley Coyote Character, Pole Position Published Illustration: Provided Liberator” pixal graphic artwork selected for the Great Computer Calendar

●Original Artwork Show: 1982 Euphrate Gallery Computer Design Show at DeAnza College, Cupertino

●Current Artwork Display: Computer Center, in Dallas Texas 2022

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