Document Control Specialist

Barbara Singh

*******@*****.*** • Milpitas, California • www.linkedin.com/in/bfsingh1206

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 deliverables. EXPERIENCE

Procept Biorobotics, Documentation Specialist (Contractor) Aug 2024 - Sep 2024

Daily tool usage: Propel, BarTender, BOX and Adobe Acrobat Reviewed and updated redlined shipping labelling changes for Regulatory approval Updated and verified redlines were incorporated for User Manual and IFU documents Gilead Sciences, QA Documentation Specialist I (Contractor) Jan 2024 - Mar 2024

Daily tool usage: GVault (Veeva Vault, RIM), 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, Labelling Specialist (Contractor)

Jan 2023 - May 2023

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, Document Control Specialist (Contractor) Oct 2022 - Nov 2022

Daily tool usage: SharePoint, MS Word, Adobe Acrobat, Slack Managed documents and records through Arena’s approval workflow Per R&D Engineering Department redlined SOPs, and Work Instructions Atara Biotherapeutics, Document Control Specialist (Contractor) Jan 2022 - Jun 2022

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, Documentation Specialist (Contractor) Nov 2021 - Jan 2022

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, Labelling Specialist (Contractor) Jul 2021 - Oct 2021

Effectively reviewed and verified rebranded outsource labels, UGs and UIs followed EU MDR standards Maintained chain of custody for controlled documents submitted to country “owner” managers AB LLC Hearing Aids and products distributed worldwide. Abbott Labs, Labelling Specialist/Print Coordinator (Contractor) Nov 2020 - Jun 2021

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 Barbara Singh - page 1 of 3

Cytek Biosciences, Document Control Specialist (Contractor) Aug 2020 - Oct 2020

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., QA Document Control (Contractor)

Feb 2020 - May 2020

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 Johnson & Johnson, Program Manager (Contractor)

Aug 2018 - Feb 2020

Program Manager for Johnson & Johnson, 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 Oracle PLM Agile 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 Prerelease documents and Approved documents from Agile to the Sharepoint Database.

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

Roche, Sr. Documentation Specialist (Permanent)

Jan 2016 - Aug 2018

Key audit liaison between Tucson/Mt. View Quality Department coordinated the preparation for notified body audits, document review, suppliers/calibrated tools, training records, license certifications, and reviewed GDP’s Liaison Record Retention Coordinator provided training for bi-annual company-wide record disposal of CDs, USBs, photos and appropriately disposed of damaged calibrated equipment Performed pre-audit document reviews: calibrated tool records, and released DHRs, BOMs/ TDs Initiated the setup for the Document Control Vault to mirror Tucson, AZ. headquarters for Clinical, Regulatory, Imaging slides, Batch Records, Log Notebooks, Calibrated Equipment, and archived Engineering binders Liaison Training Coordinator ensured all personnel training records were compliant and approved by managers Responsible for editing customer instruction guides (IG) and submitting translations (10 languages) i.e., field service guides, pamphlets, and shipping instructions

Initiated and migrated tool calibration required records to Blue Mountain Regulatory Asset Manager Roche, Sr. Change Analyst (Permanent)

Nov 2011 - Jan 2016

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

Collaborated with IT/Agile administration team in Tucson to lead the migration of 6,000 original QMS paper documents, (DCOs, BOMs, WIs, SOPs, Training/Calibrate Instruments Records) BioImagene, Sr. Documentation Specialist (Contractor) Feb 2010 - Nov 2011

Initially the DCO’s were paper-approved documents. Updated QMS paper documents transitioned to e-docs and approved and released in Oracle PLM Agile

Assisted the Regulatory team with preparation and assembling 510(K) and FDA Response Letters Improve and ensure regulatory compliance and productivity followed document processes to track version control, manage, and ensure e-docs and paper documents stored appropriately in vault. Coordinated and managed the series of multi-language User/Instructor Guides using FrameMaker, for medical device global release

D. Davis RN BSN (Clinical Trainer), Created Clinical Template 2010 - 2011

Created Informed Consent Forms, Study Protocols, Clinical Trials, SOP templates (QA Audit Plans) and Powerpoint presentations

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Loral Space System, Labelling Specialist (Contractor) Jan 2010 - May 2010

Incorporated (ECOs) for Bus Electronic procedure before routing for approval cycle Gilead Sciences, Business Analyst (Contractor)

Feb 2006 - Nov 2008

Collaborated effectively with the Business IT Process team to migrate acquired documents to Documentum Verified test plans successfully imported scanned documents Gilead Sciences, Regulatory Operations-Archivist (Contractor) Nov 2005 - Feb 2006

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, Regulatory Publisher (Contractor)

Jul 2005 - Oct 2005

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, Documentation Specialist/IQA Inspector (Contractor) Jan 2005 - Jun 2005

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, Document Specialist (Contractor) Mar 2004 - Nov 2004

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., Hardware Technical Writer (Permanent) Jan 2003 - Dec 2003

Designed Field Service online instructions: Aligned MFG hardware instructions with Step-by-Step illustrations and photos to install/replace parts for the 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 2000 - 2001

Successful Graphic Consultant for Silicon Valley Businesses – Designed Corporate Logos, Technical Writer/Editor, FrameMaker Template Designer, Adobe Illustrator, PowerPoint

EDUCATION

University of Santa Cruz (UCSC) Extension

Certificate • Web Page Design / Project Management Courses College of San Mateo

Courses to enhance technical hardware and software proficiency for career advancement. Learn It

Certified • Project Management Course

San Jose State University

BA • Art/Technical Arts

Barbara Singh - page 3 of 3

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