Justin T. Malone, Ms, Cqa Email and Phone Number
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Justin T. Malone, Ms, Cqa phone numbers
Biopharmaceutical professional with experience from Inoculum preparation to bioreactor operations and medical devices in cGMP environments. Attained my Masters degree in Leadership and Stragetic Management at Manhattanville College to advance my career through management.I would like to use my strong interpersonal skills and public speaking ability to further advance my career.Specialties: cGMP, Large Scale Manufacturing (LSM), Clinical Scale Manufacturing (CSM), Aseptic techniques,Medical Devices, SAP, Production Deadlines, Raw material implementation and ordering, Writing/Editing/Reviewing of Master Batch Records (MBRs) and Standard Operating Procedures (SOPs), implementation/closure of CAPAs and Environmental monitoring of cleanrooms.
Apollo Therapeutics
View- Website:
- apollotherapeutics.com
- Employees:
- 61
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Head Of Us Quality AssuranceApollo TherapeuticsNew York, Ny, Us -
Chief Executive OfficerJustvend Llc May 2024 - PresentProviding the best selection in vending since 2024. Our machines are located in high-traffic areas, making it easy for customers to grab their kids a quick toy. We’re committed to providing the highest level of service and products to our customers
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Chief Executive Officer/FounderIzju Travels Incorporated May 2024 - PresentProviding customers with easy travel experiences. Cars, travel plans and vacation rentals (coming soon) are all part of our customer experience.
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Principal ConsultantJ.T. Malone Enterprises Oct 2022 - PresentProviding clients with technical and quality assurance support. Primary focus is on remediation activities, audits, change control management, investigations, batch records (creation & reviews), Quality leadership and project management activities.Represents clients as QPIP (Quality Person in Plant) for Phase 1b to Commercial drug substance and drug product run.
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Us Quality AssuranceBlack Diamond Networks Dec 2022 - Mar 2023Andover, Massachusetts, Us• Review and approve MBR, SOPs, EBRs, TTPs, Validation reports and other related documents• Provide quality oversight of activities performed by 3rd Parties or suppliers (i.e., Audit adherence; Quality Agreements), as required by applicable internal Standards and Regulatory authorities• Authoring, reviewing, approving, and maintaining Standard Operating Procedures• Dispositions large molecule products• Reviews and approves all internal and vendor deviations, change controls & CAPAs -
Associate Director Quality AssuranceAvalo Therapeutics Feb 2022 - Jan 2023Rockville, Maryland, Us• Schedules and preforms vendor & internal audits as Lead Auditor• Review and approve MBR, SOPs, EBRs, TTPs, Validation reports and other related documents• Track, review and approve deviations (internal/external) and OOSs • Author, review, approve audit plans, conduct audits at 3rd party vendors and issuance of audit findings• Quality Person in Plant duties as needed • Functional Quality Lead on multiple small and large molecule products• Provide quality oversight of activities performed by 3rd Parties or suppliers (i.e., Audit adherence; Quality Agreements), as required by applicable internal Standards and Regulatory authorities• Authoring, reviewing, approving, and maintaining Standard Operating Procedures• Dispositions small and large molecule products -
Principal ConsultantJ.T. Malone Consulting Llc Jan 2016 - Oct 2022Providing clients with technical and quality assurance support. Primary focus is on remediation activities, audits, change control management, investigations, batch records (creation & reviews) and project management activities.
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Director Of Quality Management Systems And ComplianceWuxi Biologics Dec 2021 - Mar 2022Wuxi, Jiangsu, Cn-Oversees deviation, change controls and CAPA management-Chair of Change Control Review Board-Hosts and schedule all client audits-Manages outcomes from client audits-Lead auditor for vendor and supplier audits-Authors Quality Agreements -Chair of monthly Quality Council Meeting -Oversees all document control via MasterControl -
Associate Director Quality AssuranceWuxi Biologics Jan 2021 - Dec 2021Wuxi, Jiangsu, Cn-Review and approve QA documents including SOPs, Change Controls, URS, FAT, SATs, various protocols-Schedules & performs vendor audits -Head of Vendor Management program -Works cross functionally to ensure manufacturing will be completed on time -Ensures all manufacturing activities are completed using cGMP-Leads investigations within manufacturing area-Leads team of QA specialist that are responsible for recording QA observations during the manufacturing process-QA Functional Lead for various PD and Clinical cGMP products -
Senior Project Manager, Global Pharmaceutical Development And OperationsCelgene Sep 2019 - Jan 2021Summit, New Jersey, Us -
Lead InvestigatorAkorn Jun 2019 - Sep 2019
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Manufacturing SmeAegerion Pharmaceuticals Limited Feb 2019 - Jun 2019 -
Senior Manager, Product Disposition, BiologicsAmicus Therapeutics Oct 2016 - Feb 2019Princeton , Nj, Us -
Gmp- Qa Batch Records Review ManagerAmicus Therapeutics Apr 2016 - Oct 2016Princeton , Nj, Us -
Technical Investigation WriterKaztronix Llc (G&W Labs) Dec 2015 - May 2016Arlington, Virginia, Us -
Product Release Specialist-QaShire Jun 2014 - Dec 2015Tokyo, Jp, Jp•Received “Operational Excellence Award” for helping successfully launch Revestive in European market•Member of Natpara Launch Team; team successfully launched and supplied product ahead of projected schedule•Managed five Contract Manufacturer Organizations (Domestic and International) to ensure timely release of products•Audited data for company’s IND reports•Member of team that co-authored current SOP on “Disposition of Clinical and Commercial Products”•Review of Batch Records and/or Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release as per NPS requirements -
Quality Specialist-Consultant (C&G Consulting)Shire Mar 2014 - Jun 2014Tokyo, Jp, Jp•Review of Batch Records and/or Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release as per NPS requirements•Manage process of tracking errors in Batch Records and/or DHRs and report to management of any inconsistencies•Work with quality counterparts at CMO’s to resolve issues related to batch record and/or DHRs review•Prepares appropriate documentation for final disposition process of NPS products•Review of all lot associated deviations, CAPAs and change controls -
Contractor- Quality Document Review Specialist For Merck Spo Quality GroupSpectraforce Technologies Jun 2013 - Apr 2014Duties include reviewing all production vaccine batch records for SPO (Sterile Production Operations). Ensuring all production batch records adhere to federal and international guidelines. Initiating EN (Event Notifications) for non-conformances and deviations. Working closely with operators, leads and supervisors to ensure timely comment resolution for batch records. Approving and entering lot related information into SAP and Trackwise.
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Manufacturing Supervisor (Grafton Bone Graft)Medtronic Spine & Biologics Jan 2013 - Apr 2013Minneapolis, Mn, UsSupervision over multiple manufacturing associates and seven Grafton product lines.Providing career guideline to manufacturing associates. Ensuring all cGMP guidelines are understood and followed.Ensuring all raw materials are stocked and within expiry dates. Ensuring all production deadline are met in accordance with financial forecast. Entering/Planning/Edit production lots within SAP system. Second shift emergency response site leader.Working closely with Engineering, QA,QC,Maintenance, Packaging & Shipping and Planning groups to ensure all products are within specification for release. -
Manufacturing Supervisor (Magnifuse Bone Graft)Medtronic Spine & Biologics Jun 2012 - Apr 2013Minneapolis, Mn, UsSupervision over multiple manufacturing associates.Providing career guideline to manufacturing associates. Ensuring all cGMP guidelines are understood and followed.Ensuring all raw materials are stocked and within expiry dates. Ensuring all production deadline are met in accordance with financial forecast. Entering/Planning/Edit production lots within SAP system. Second shift emergency response site leader.Working closely with Engineering, QA,QC,Maintenance, Packaging & Shipping and Planning groups to ensure all products are within specification for release. -
Scientist (Shift Lead)Laureate Pharma Oct 2011 - Jun 2012Responsible for development, optimization, implementation and validation of cGMP methods for mammalian cell-derived biopharmaceutical products. Conducts the implementation of production procedures to optimize manufacturing processes and regulatory requirements. Assist process development in developing scalable processes with improved product yield and reduced costs for manufacturing systems. May research and implement new methods an technologies to enhance operations. Work on extreme complex problems where analysis of situations or data requires an evaluation of intangible variables. Excercise independent judgement in developing methods, techniques and evaluation criteria for obtaining results. Act independently to determine methods and procedures on new projects and manage the activities of other junior scientists
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Associate Manufacturing ScientistProgenics Pharmaceuticals Mar 2010 - Sep 2011New York, New York, UsDuties include scheduling cell expansion activities, setting up production bioreactors for SIP (Steam In Place) and CIP (Clean In Place), performing SIP and CIP operations, ordering Upstream Manufacturing supplies, daily monitoring of MCB (Master Cell Bank), performing raw material implementation planning for PSMA mAb (GS CHO cell line), scheduling PMs (Preventive Maintenance) and maintenance contracts for Vi-Cell and Nova Bioprofile Analyzer, writing and reviewing SOPs and Batch Records -
Assistant Manufacturing ScientistProgenics Pharmaceuticals, Inc Feb 2008 - Mar 2010Duties include media preparation and inoculum preparation, performing vial thaws, daily samples and media additions on CHO cell line daily monitoring of freezer and cold box temperature charts, monthly environmental monitoring of clean rooms, post testing of media preparation filters, performing daily, monthly and semi-annual cleans of BSC (Biological Safety Cabinet), performing static environmental monitoring, preparing sterile tubing assemblies, writing and revising of Manufacturing Batch Records and SOPs, writing change controls , preparing GMP samples for QA testing, monitoring raw material usage in manufacturing area, assisting in the start of a new cell line/ product (PSMA Campaign)
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Manufacturing AssociateAmgen West Jan 2006 - Oct 2007Duties include sampling product to monitor for contaminations, setting up production vessels for SIP's (Steam In Place) and CIP's (Clean In Place), performing SIP's and CIP's, calibrating pH and DO probes and various other lab equipment, pre/post-testing of production filters, decommissioning of production equipment
Justin T. Malone, Ms, Cqa Education Details
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Villanova UniversityApplied Project Management -
Manhattanville UniversityLeadership And Strategic Management -
Temple UniversityBiology
Frequently Asked Questions about Justin T. Malone, Ms, Cqa
What company does Justin T. Malone, Ms, Cqa work for?
Justin T. Malone, Ms, Cqa works for Apollo Therapeutics
What is Justin T. Malone, Ms, Cqa's role at the current company?
Justin T. Malone, Ms, Cqa's current role is Head of US Quality Assurance.
What is Justin T. Malone, Ms, Cqa's email address?
Justin T. Malone, Ms, Cqa's email address is jm****@****ail.com
What is Justin T. Malone, Ms, Cqa's direct phone number?
Justin T. Malone, Ms, Cqa's direct phone number is +120321*****
What schools did Justin T. Malone, Ms, Cqa attend?
Justin T. Malone, Ms, Cqa attended Villanova University, Manhattanville University, Temple University.
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