PROFILE:

Experience in the design, implementation and management of quality document systems in the pharmaceutical, medical device, biotechnology, molecular diagnostic and dietary supplements industries. Trained in the latest international and national industry standards and regulations. Familiar with material handling, inspection processes, equipment calibration and qualification / validation.

PROFESSIONAL EXPERIENCE:

Pharmaceutical Product Development (PPD), Wilmington, NC March 2020-Current

Contractor, Zymeworks BioPharmaceutical, Seattle, WA March 2020-March 2021

Closure of historical external and internal deviation, which entailed completing deviation forms using vendors’ quality events reports to record the cause, severity, corrective action, quality event completion, reviewed for Good Documentation Practice (GDP) and updated Excel spreadsheet with data from deviation forms.

Conducted assessment of more than 3,200 manufacturing and quality documents within the Electronic Document Management System (EDMS). With a critical impact on a 2021 partner audit, concentrated on, quantifying and resolving issues of duplicate records, typographical errors, files with more than one document types, files with no company or vendor lot number, problematic titles, and GDP.

Created binders in the EDMS, which serve as repository for vendor lot file documents. Uploaded documents within binders, completed metadata, and created vendor lot tree checklists to determine gaps within vendor repository.

Created first drafts of lot review process, vendor lot review checklist, and management of lot file binders, which includes a high-level process flowchart and screenshots.

Developed vendor review trackers an aid to checking executed batch record.

Threshold Enterprises, Ltd., Scotts Valley, CA March 2010-June 2018

Quality Assurance (QA) Document Control Coordinator

Executed and administered the day-to-day document control activities, recommended and implemented process and procedure improvements, and ensured compliance with government regulations and corporate procedures.

Implemented quality logbook program, which included submitting requisitions to Purchasing to order logbooks, issuing and controlling all logbooks, and archiving completed logbooks.

Managed laboratory notebook programs for Quality Control department and Threshold Research & Development and Production departments that involves issuing, auditing and archiving.

Project Manager for plan to convert the manual Quality Management System to an automated / electronic effort to effectively manage quality systems documents, in support of compliance with 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, and 21 CFR Part 11 Electronic Records; Electronic Signatures.

Created and updated quality system procedures.

Served as member of the Audit Team.

Served as member of Quality Assurance / Quality Control Product Testing, Sampling Plan Team.

Administered storage of archival, legacy quality records retained for the established retention period, provided archival storage boxes, arranged for onsite storage and retrieval, and managed disposition of records that have fulfilled their retention requirements.

Navigenics Laboratory (formerly Affymetrix Clinical Services Laboratory (ACSL)), West Sacramento, CA January 2008-August 2009

ACSL – Sr. Document Control Specialist

Navigenics Laboratory – Independent Consultant

Managed document change notice (DCN) system which included generating, reviewing, editing, approval, implementing and distributing quality documents

Managed calendar of scheduled regulatory submissions, quality assurance tasks and equipment calibration and maintenance

Maintained Safety Data Sheets (SDS) system

Controlled master laboratory equipment database

Monitored asset tag process for laboratory equipment

Organized and processed states’ laboratory permit licensure submissions

Managed quality, regulatory and clinical laboratory standards library

Reviewed for accuracy, supplier’s equipment calibration certificates

Maintained training binders

Reviewed submission documentation, and assisted with Institutional Review Board (IRB) submissions and renewals

Kelly Engineering, Sunnyvale, CA; West Sacramento, CA June 2006-December 2007

Contractor, Affymetrix Clinical Services Laboratory (ACSL), Sunnyvale and West Sacramento, CA

Developed and implemented, with the laboratory manager, the quality system of a molecular diagnostic clinical services laboratory in compliance with Clinical Laboratory Improvement Amendments (CLIA), 42 CFR Part 493 Laboratory Requirements, and ISO laboratory regulations

Managed the document change notice (DCN) system which involved generating, reviewing, editing, approving, implementing and distributing quality documents

Developed and managed a calendar of scheduled quality assurance tasks, and equipment calibration and maintenance

Developed and maintained SDS system

Created and maintained master laboratory equipment database

Managed the quality, regulatory and clinical laboratory standards library

Reviewed for accuracy supplier’s equipment calibration certificates

NovoStent Corporation, Mountain View, CA October 2005-April 2006

QA Associate

Managed the Document Control activities, including:

-Processed document change order (DCO) generation, approval, processing and distribution of quality documents

-Established training matrix and identified training gaps

-Compiled computer software & hardware log in preparation for validation activities to satisfy 21 CFR Part 11, Electronic Records; Electronic Signatures.

-Prepared essential industry standards list and ordered standards for company library

-Generated equipment documentation to prepare for production level use

-Structured the Design History File system

Performed Inspection and Material Handling, such as:

-Identified incoming items, issued lot numbers and distributed items as required;

-Inspected components, documented and performed inspection activities, generated and implemented first article request and non-conformance reports, communicated with suppliers for missing documentation

-Performed inventory control and established stores of components, raw materials and products

ConforMIS, Inc. & Imaging Therapeutics, Inc., Foster City, CA January 2004-August 2005

Document Control Specialist.

Managed FileMaker Pro database for issuing document and document change orders (DCO) numbers

Processed and released all DCOs, ensuring compliance with change order procedure, completeness and accuracy of data, resolving discrepancies, and distributed and retrieved controlled copies

Maintained hard copy and electronic files of approved documents, and implemented security controls

Wrote laboratory notebook SOP, and managed company lab notebook program

Maintained company quality system training records

Managed the quality, regulatory and clinical standards library

Quality Associate

Received, identified and inspected raw materials

Prepared documentation and packaging of product to be sent to sterilization contractor

Reviewed completed product lot history records and final acceptance of product

Assisted with managing the Material Review Board (MRB), Non-conformance Report (NCR) and Corrective and Preventive Action (CAPA) systems

Participated in supplier/vendor evaluation

Aided in developing and managing the equipment calibration and preventive maintenance systems

Contributed to the implementing and validating of an onsite Vaporized Hydrogen Peroxide (VHP) sterilization system

-Wrote SOP and work instructions on VHP sterilization

-Created part specifications for biological and chemical indicators, and hydrogen peroxide sterilant

Customer Service

Maintained database using FileMaker Pro which issued product part numbers, and created the Sales Order documentation, generated Sales Update Report and Internal Status product list

Prepared product to be shipped to customer, ensuring compliance with shipping regulations

Issued purchase orders and maintained files for the procurement of Research & Development and manufacturing materials

On Assignment – Lab Support, Campbell, CA December 2002-December 2003

Contractor, Allergan, Inc., Campbell, CA

Updated and maintained Quality Control databases for equipment calibration and preventive maintenance systems

Developed, using information from existing Manufacturing Instructions, a spreadsheet of raw materials used in product manufacturing with data for manufacturer and part numbers

Assisted with the disposition of raw materials, cleaning agents and QC testing materials

Performed audit of the validation hardcopy files, organized documents by system, and updated the validation database

PercuSurge Medtronic, Inc., Sunnyvale, CA June 2001-July 2002

Document Control Supervisor

Supervised and coordinated activities of staff of 2 employees engaged in maintaining the quality documentation system in compliance with 21 CFR 820 Quality System Regulation

-Determined work schedules and expedited workflow by directing and assisting staff in storing, retrieving, checking, correcting and copying electronic, digital and hardcopy documents

-Examined work for exactness, neatness and conformance to policies and procedures

-Conducted and coordinated audits of files and filing systems as directed by management

-Wrote staff performance evaluation and development plans

Chaired Change Control Board (CCB) meeting, wrote and distributed the agendas and meeting minutes

Boston Scientific Quanam, Santa Clara, CA January 2001-June 2001

Document Control Specialist

Re-structured, with Quality Assurance Consultant, the company Document Control system to comply with 21 CFR 820 Quality System Regulation

-Reviewed and reissued documentation such as Procedures, Work Instruction, Bills of Materials and Travelers, Manufacturing Instructions, Equipment Instructions, Component Specifications, and Drawings

Audited company lab notebook program for compliance. Revised SOP to ensure lab notebooks were easier to identify, confidential and suited for microfilming

Affymetrix, Inc., Santa Clara, CA May 1999-January 2001

Document Control Analyst

Processed corporate documentation using Documentum an Electronic Document Management System (EDMS). Analyzed and processed Engineering Change Orders (ECOs) determining content correctness, completeness and compliance with 21 CFR 820 Quality System Regulation and 21 CFR part 11 Electronic Records; Electronic Signatures

Administered system for process, product, and system deviations; identifying authorized approvers, implementing, and creating a deviation status report

Managed corporate product batch record system using a company developed Microsoft Access database

Identified and prepared older records for offsite storage using Microsoft Access database

Used Loftware Label Software to develop, design and print customer product labels; troubleshooting and problem solving printer concerns and label print quality

Conducted audit of over 1000 existing labels for Y2K compliance, and validated software for Y2K compliance

EDUCATION/TRAINING:

Regulatory/Quality Training

Provided By:

Establishing and Managing Successful Records Management

Washington State University Seminar Series

FDA Investigation New Drug (IND) Process

Drug Information Association Workshops

FDA New Drug Application (NDA) Process

Drug Information Association Workshops

Pharmaceutical Documentation

Drug Information Association Workshops

Good Manufacturing Practice, Quality System Requirements

American Society of Quality Training

Good Clinical Practice Training

Drug Information Association Workshops

Good Laboratory Practice Training

Drug Information Association Workshops

Audits (FDA, Notifying Body, Internal)

American Society of Quality Training

Qualification of Computerized Systems; Electronic Document Management System Validation Training

Consultant (Former FDA employee)

Training for 21 CFR Part 11 Compliance

Medtronic Corporation

COMPUTER SKILLS & TRAINING:

Microsoft Word, Excel, Access and PowerPoint; Visio

Adobe Acrobat

FileMaker Pro, and TurboCAD

Documentum; AutoManager

NovaSoft, Inc., NovaManage System Administrator's Training; Document Services Users Training

Agile version, Anywhere Administrator Training; Content Manager Training; Workshop Training

Introduction to Web Design; Introduction to HTML

Veeva Systems

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