Marie G Beltran work email
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Marie G Beltran personal email
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*Open to professional opportunities in cGMP QA/QC, lab operations, and leadership roles in QC microbiology.*Experienced trainer for cGMP pharmaceutical laboratory and manufacturing plant environments.*Interested in gaining additional experience with auditing, investigations (CAPA, CC, deviations), risk management, data integrity and management, manufacturing facility/clean room (design, compliance and qualification), project management, and consulting.*Diverse background and wide breadth of technical experience gained from R&D/academia/clinical/GLP, cGMP/QC, biopharmaceutical, and biotechnology settings in a FDA regulated environment. Recent focus has been with a biotech startup, global biopharma, medical device, and CDMO.*Over two decades in the field with an emphasis on cGMP compliance in areas of functional assays and methodologies to support facility testing, lot release, stability, and validation studies (QC). *Experience with clinical product lot file upload, compilation, package verification; external vendor deviations and quality hold assessments; technical writing to support system improvements and audit findings (QA). *Experience working with senior quality management, project managers, quality teams, and client stakeholders on nonconformances and change controls.*Usage of eQMS and support data maintenance software: Veeva, QDM, AIM-QMS, MasterControl, TrackWise, Maximo, Blue Mountain, Apollo, Pluto, Vitek2, Observa, MODA, and ComplianceQuest.*Ability to work effectively across cross-functional teams, practical laboratory operations experience, continuous process improvements involving risk management and human error reduction following two FDA site audits.*Involvement with procurement and asset management scheduling, fostered vendor relationships, and addressed annual vendor re-qualifications and complaints.*Seasoned professional with a can-do attitude, proven experience and proactive approach to get things accomplished. It is my goal to contribute practical ways to identify, address, solve issues, and to help meet objectives while keeping cost-efficiency, safety, compliance, and seamless lab operations at the forefront. *Innovative cancer immunotherapies, rapid microbiological methodologies, project management, and culinary trends remain areas of interest.*Previous memberships: PDA, ASQ, BBGA, HOA board member. *Active Yelp WA/greater Seattle Elite and Instagram contributor promoting local and independent businesses.*Enjoy culinary and urban pursuits, gardening, and local sports enthusiast.
Just-Evotec Biologics Via Oxford Global Resources
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Senior Qc Compliance Consultant / Quality CoordinatorJust-Evotec Biologics Via Oxford Global Resources Oct 2023 - PresentData analytics, technical writing, interaction with QA, QC, project managers, and their clients to address deviations and initiate change controls.Proficient with eQMS, ComplianceQuest.Community member, CityWise Project for City of Shoreline, February-April 2024Completed "Writing in the Sciences" July/August 2023 and "Design and Analysis of Clinical Trials" October 2023 via Coursera, Stanford University
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Quality Systems SpecialistBio-Rad Via Entegee Nov 2022 - May 2023Provide cross functional departmental Quality Management Systems support for Seattle Operations.Initiation, monitor, and completion of change control and document revision requests.Assist with QMS database entry, tracking and archival projects.Technical review and document revisions to support audit findings.
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Qa Specialist, Quality Operations - Global Product DispositionSeagen Via Actalent Jun 2021 - Nov 2021Completed documentation uploads from external vendor sites (US, UK, Germany) to initiate clinical lot file folders and forwarded lot files for approval (Veeva)Performed package verification of clinical lots from internal specifications, vial and packaging labelingProcured data for lot file compilation from eQMS sites (Veeva, QDM, AIM-QMS, internal/CMO Sharepoint sites)Initiated external site deviations and quality hold assessments (Veeva)Participated in new and revised operating procedure process (Veeva), Material Review Board scribe
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Regulatory Affairs / Quality Control SpecialistLumen Bioscience Jan 2021 - Mar 2021Seattle, Wa, UsProvided overview assessment for R&D and GMP lab areasIdentified FDA auditing guidelines, regulatory reference documents, training opportunities, and external auditorsIntroductory overview training on MiSeq system, Jess, TECAN, and eQMS systemsCompiled ordering lists for prioritized assays for new QC lab spaceSpot checked external testing site results for OOS testing statusInitiated external accounts for bacterial/fungal identification and USP 61/62 regulatory testingTrained on proprietary ELISAs and ATP cell viability assay for Spirulina constructsWrote preliminary draft for assay transfer from R&D to QC QC MicrobiologistMember, Parenteral Drug Association -
Senior Qc Analyst, MicrobiologyPartner Therapeutics Feb 2018 - Oct 2020Received awards: Order Coordinator (2018) and Shooting Star (2020) for successful partnerships with Procurement, Accounts Payable/Finance, Material Management, and external vendors at PTx-Northpointe.Primary ordering coordinator: worked directly with Procurement, Accounts Payable, Material Management, and external vendors.Primary asset management scheduler: worked directly with AMS-Maximo coordinators, Lab Services, Facilities, Engineering, Security, and external vendors. Completed asset and work order reviews for on demand, monthly and annual basis.Primary contact: vendor requalifications and complaints; annual equipment service and contract renewals; partnered with Quality Assurance. Qualified trainer and analyst: bioburden/membrane filtration analysis, non-host testing, and liquid media lot qualifications for manufacturing in-process/release and validation test samples.Qualified analyst: microbial identification, media lot qualification/release, cell banking, and data review. Proficiency demonstrated using AMS-Maximo, LIMS, Apollo, Vitek2, Observa, and MODA data systems.Qualified MasterControl analyst: initiate and complete document revisions, initiate deviations, complete action items. Coordinated and initiated activities for IQ/OQ/PV of MALDI-TOF system. Team member to facilitate onboarding of departmental lab equipment.HACCP, risk management, and 5S team member: evaluate release assays and periodic document review to address continuous improvement, human error prevention, and compliance enhancements.Attended 14th Annual PDA Pharmaceutical Microbiology Conference, Rockville MD, Oct 2019Member, Parenteral Drug Association
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Senior Qc AnalystSanofi Apr 2015 - Jan 2018Paris, France, FrSenior QC Analyst, QCBFTSanofi, Northpointe Specialty Care - Biologics, Lynnwood WA(11/2/15 - 1/31/18)Senior QC Analyst via Lab Support at Genzyme, a Sanofi company- Northpointe site, Lynnwood WA(4/27/15 - 11/1/15)Provide QC microbiology support for QCBFT departmentManufacturing site for Leukine® (sargramostim)Cross-functional interactions with other QC, QA, Manufacturing, Facilities, Engineering, Validation, AMS, IT, Materials Management, HSE, Regulatory, Procurement, Accounts Payable, and Finance departments within a large GMP pharmaceutical facility settingTimely completion of major QCMV projects with QCBFT team, senior-level QC scientists, project managers, and consultants for critical corporate and regulatory deadlinesIntegrating manufacturing, validation sample time points, and asset management work orders with QCBFT departmental schedulingCultivate vendor relationships to maintain lab inventory, equipment calibration/preventive maintenance, external vendor testing, and support QC development studiesCoordinate asset management (equipment calibration/preventive maintenance) via Maximo 7.5Collaborate with QA with document revisions, subcontractor qualifications, product investigations, vendor complaints, deviations, and CAPAsActive participant with EMPQ and 5S project teams, ARR QCBFT site coordinatorCompleted trainer status to support validation and manufacturing sample receipt for membrane filtration/bioburden analysisQualified analyst for microbial ID and media lot qualification/releaseQualified analyst for non host release assay for in-process manufacturing batch samplesCross-trained several QC Analysts in QCBFT operations and quality systems Corporate site system usage including LIMS, RTIP, TrackWise, My Learning Center, Pluto, and Vitek2/ObservaTeam recipient of Q4 2015 Impact Award, Feb 2016Member, American Society of Quality -
Cgmp/Qc Microbiologist And Biotechnology ProfessionalCrossroads Transition May 2014 - Apr 2015Completed UWPCE and UCSD Extension Biotechnology Project Management CertificationMember, American Society of QualityBread tester for second publication from Modernist Cuisine - Intellectual VenturesAudited courses in flow cytometry (Shoreline CC) and immunology (edX, Rice University)
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Associate Scientist IiEmergent Biosolutions, Inc. Dec 2013 - May 2014Gaithersburg, Maryland, UsFormerly known as Emergent Product Development Seattle, Process and Analytical Development - Bioassay (8/1/16 - became Aptevo Therapeutics)Completed growth inhibition assay protocol evaluation and compiled results in a comprehensive development reportPerformed growth inhibition assay via CD37 binding and cross linking using luminescence ATP detection system for stability testingPerformed CD37 and CD16 binding assay using PE conjugated stain for stability testingDemonstrated consistent cell culture propagation and maintenance of Daudi, Jurkat, Rec-1Member, American Society of Quality -
Senior Qc Associate IDendreon Corporation Jul 2008 - Feb 2012Seal Beach , Ca, UsSupported cGMP/Patients First activities and assays for QC Operations: Microbiology, In Vitro Biology, Biochemistry, and Raw Materials, including critical utilities monitoring, stability, bulk, and lot release assay focusCorporate QC Microbiology Trainer for NJ, GA, and CA manufacturing sites and lead QC microbiology analyst at WA corporate siteTrainer for AIM-V media release assay for all manufacturing sites, assay transferred to CA siteExperienced with aseptic technique and cell culture: TF-1, Jurkat, Sf21, Papillon, FPRCInteraction with QA and validation teams to support facility move and IQ/OQ/PQ activities Member, American Society of Quality
Marie G Beltran Skills
Marie G Beltran Education Details
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University Of WashingtonMicrobiology -
University Of Washington Professional And Continuing Education And Uc San Diego ExtensionBiotechnology Project Management Certification
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Seattle Central Community College / Seattle Culinary AcademySpecialty Desserts And Breads (Pastry Program)
Frequently Asked Questions about Marie G Beltran
What company does Marie G Beltran work for?
Marie G Beltran works for Just-Evotec Biologics Via Oxford Global Resources
What is Marie G Beltran's role at the current company?
Marie G Beltran's current role is cGMP Quality Specialist / QC Microbiologist.
What is Marie G Beltran's email address?
Marie G Beltran's email address is be****@****ton.edu
What schools did Marie G Beltran attend?
Marie G Beltran attended University Of Washington, University Of Washington Professional And Continuing Education And Uc San Diego Extension, Seattle Central Community College / Seattle Culinary Academy.
What skills is Marie G Beltran known for?
Marie G Beltran has skills like Primary Cell Culture Isolation, Writing, Laboratory, Westerns, Elisa, Lal, Hplc, Lab Operations, Gmp, Assay Development, Technical Training And Writing, Northerns.
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