| Candidate Information | | Title | Quality Assurance Document Control Specialist | | Target Location | US-WA-Seattle |
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Click here or scroll down to respond to this candidatePROFILE:Skilled 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.Experience in handling mechanical engineering documents, in compliance with American Society of Mechanical Engineers (ASME) industry Y14 standards, Engineering Product Definition and Related Documentation Practices.PROFESSIONAL EXPERIENCE:IT Network, ContractorChemithon Corporation, West Seattle, WA May 2021-March 2024Ensured the safety, security, and archival of engineering documents.Ensured the accuracy of engineering documents for issuing and release.Printed, scanned, and distributed engineering documents within the company.Transmitted and uploaded deliverables to customers data portals.Ensured the accuracy, completion and distribution of change control and datasheets documentation.Established for new projects, documentation tools to monitor status for each component of the engineering projects.Pharmaceutical Product Development (PPD), Wilmington, NC March 2020-CurrentContractor, Zymeworks BioPharmaceutical, Seattle, WA March 2020-March 2021Closure 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.Created a work instruction for the process with steps to avoid gaps.Threshold Enterprises, Ltd., Scotts Valley, CA March 2010-June 2018Quality Assurance (QA) Document Control CoordinatorExecuted 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 2009ACSL Sr. Document Control SpecialistNavigenics Laboratory Independent ConsultantManaged document change notice (DCN) system which included generating, reviewing, editing, approval, implementing and distributing quality documentsManaged calendar of scheduled regulatory submissions, quality assurance tasks and equipment calibration and maintenanceMaintained Safety Data Sheets (SDS) systemControlled master laboratory equipment databaseMonitored asset tag process for laboratory equipmentOrganized and processed states laboratory permit licensure submissionsManaged quality, regulatory and clinical laboratory standards libraryReviewed for accuracy, suppliers equipment calibration certificatesMaintained training bindersReviewed submission documentation, and assisted with Institutional Review Board (IRB) submissions and renewalsKelly Engineering, Sunnyvale, CA; West Sacramento, CA June 2006-December 2007Contractor, Affymetrix Clinical Services Laboratory (ACSL), Sunnyvale and West Sacramento, CADeveloped 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 regulationsManaged the document change notice (DCN) system which involved generating, reviewing, editing, approving, implementing and distributing quality documentsDeveloped and managed a calendar of scheduled quality assurance tasks, and equipment calibration and maintenanceDeveloped and maintained SDS systemCreated and maintained master laboratory equipment databaseManaged the quality, regulatory and clinical laboratory standards libraryReviewed for accuracy suppliers equipment calibration certificatesNovoStent Corporation, Mountain View, CA October 2005-April 2006QA AssociateManaged 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 systemPerformed 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 productsConforMIS, Inc. & Imaging Therapeutics, Inc., Foster City, CA January 2004-August 2005Document Control Specialist.Managed FileMaker Pro database for issuing document and document change orders (DCO) numbersProcessed and released all DCOs, ensuring compliance with change order procedure, completeness and accuracy of data, resolving discrepancies, and distributed and retrieved controlled copiesMaintained hard copy and electronic files of approved documents, and implemented security controlsWrote laboratory notebook SOP, and managed company lab notebook programMaintained company quality system training recordsManaged the quality, regulatory and clinical standards libraryQuality AssociateReceived, identified and inspected raw materialsPrepared documentation and packaging of product to be sent to sterilization contractorReviewed completed product lot history records and final acceptance of productAssisted with managing the Material Review Board (MRB), Non-conformance Report (NCR) and Corrective and Preventive Action (CAPA) systemsParticipated in supplier/vendor evaluationAided in developing and managing the equipment calibration and preventive maintenance systemsContributed 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 sterilantCustomer ServiceMaintained database using FileMaker Pro which issued product part numbers, and created the Sales Order documentation, generated Sales Update Report and Internal Status product listPrepared product to be shipped to customer, ensuring compliance with shipping regulationsIssued purchase orders and maintained files for the procurement of Research & Development and manufacturing materialsOn Assignment Lab Support, Campbell, CA December 2002-December 2003Contractor, Allergan, Inc., Campbell, CAUpdated and maintained Quality Control databases for equipment calibration and preventive maintenance systemsDeveloped, using information from existing Manufacturing Instructions, a spreadsheet of raw materials used in product manufacturing with data for manufacturer and part numbersAssisted with the disposition of raw materials, cleaning agents and QC testing materialsPerformed audit of the validation hardcopy files, organized documents by system, and updated the validation databasePercuSurge Medtronic, Inc., Sunnyvale, CA June 2001-July 2002Document Control SupervisorSupervised 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 plansChaired Change Control Board (CCB) meeting, wrote and distributed the agendas and meeting minutesBoston Scientific Quanam, Santa Clara, CA January 2001-June 2001Document Control SpecialistRe-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 DrawingsAudited company lab notebook program for compliance. Revised SOP to ensure lab notebooks were easier to identify, confidential and suited for microfilmingAffymetrix, Inc., Santa Clara, CA May 1999-January 2001Document Control AnalystProcessed 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 SignaturesAdministered system for process, product, and system deviations; identifying authorized approvers, implementing, and creating a deviation status reportManaged corporate product batch record system using a company developed Microsoft Access databaseIdentified and prepared older records for offsite storage using Microsoft Access databaseUsed Loftware Label Software to develop, design and print customer product labels; troubleshooting and problem solving printer concerns and label print qualityConducted audit of over 1000 existing labels for Y2K compliance, and validated software for Y2K complianceEDUCATION/TRAINING:Regulatory/Quality TrainingProvided By:Establishing and Managing Successful Records ManagementWashington State University Seminar SeriesFDA Investigation New Drug (IND) ProcessDrug Information Association WorkshopsFDA New Drug Application (NDA) ProcessDrug Information Association WorkshopsPharmaceutical DocumentationDrug Information Association WorkshopsGood Manufacturing Practice, Quality System RequirementsAmerican Society of Quality TrainingGood Clinical Practice TrainingDrug Information Association WorkshopsGood Laboratory Practice TrainingDrug Information Association WorkshopsAudits (FDA, Notifying Body, Internal)American Society of Quality TrainingQualification of Computerized Systems; Electronic Document Management System Validation TrainingConsultant (Former FDA employee)Training for 21 CFR Part 11 ComplianceMedtronic CorporationCOMPUTER SKILLS & TRAINING:Microsoft Word, Excel, Access and PowerPoint; VisioAdobe AcrobatFileMaker Pro, and TurboCADDocumentum; AutoManagerNovaSoft, Inc., NovaManage System Administrator's Training; Document Services Users TrainingAgile version, Anywhere Administrator Training; Content Manager Training; Workshop TrainingIntroduction to Web Design; Introduction to HTMLVeeva Systems |
