Frank Cooney Email and Phone Number
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Frank Cooney personal email
GxP Quality Assurance ProfessionalExperience in ISO/CAP accredited laboratories, API and DP manufacturing and clinical research.Adept in process control and statistical methods.
Lumos Pharma
View- Website:
- lumos-pharma.com
- Employees:
- 46
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Quality And Compliance SpecialistLumos PharmaMonument, Co, Us
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Sr. Quality AssociatePfizer Apr 2021 - PresentNew York, New York, UsQuality Lead for global projects within the small molecule portfolio collaborating with internal functional areas, external CMOs and partner pharmaceutical companies assuring compliant GMP drug products Quality review of project related documents including pre and post executed batch records, product specifications, internal and external change controls and deviation investigations, quality assurance agreements Worked cross functionally with internal and external department lines including supply chain, regulatory, analytical and inventory management to advance clinical supply goals and resolve issues and deviations Company qualified global trainer developing and delivering on-the-job training for operations and portfolio quality assurance colleagues Key contributor on process improvement teams addressing SOP improvements and to increase work efficiency and compliance Systems Used: Trackwise and Veeva Vault for quality records review, Laboratory Information Management System for laboratory data review, Global Documentation Management System (GDMS) for document management, Inventory system for product disposition -
Quality Assurance ManagerPcm Trials - Quality Mobile Research Sep 2019 - Apr 2021Denver, Colorado, UsImplemented and managed Quality Management System (QMS), including investigations, CAPAs, procedure development, training, document management, vendor management and audits to support decentralized clinical trials for CROs and pharmaceutical sponsors Tracked project issues for ~70 clinical projects and worked closely with project managers to implement CAPAs Managed compliance with applicable regulatory requirements and standards including ICH e6, ISO 9001 and EMA guidance Quality representative for company-wide initiatives including Workday implementation for training development and delivery Quality representative for COVID task force providing policies and guidance for continued business operations during the COVD-19 pandemic Workday administrator creating and managing general GCP and protocol specific training provided to a nation-wide network of project managers and research nurses Systems Used: Microsoft Office Suite, Workday -
Manufacturing Quality EngineerAgilent Technologies Feb 2016 - Sep 2019Santa Clara, Ca, UsQuality assurance review of batch records/data in compliance with GMP for the manufacturing of active pharmaceutical ingredients (API).Support of deviation investigation report writing including Root Cause Analysis (5 Whys, 5Ms) and CAPAs.Quality review and approval of manufacturing investigations.Metric creation and compilation for quality indicators using MS excel and pivot tables.Management of Sharepoint for quality department information.Management of Smartsheet for quality department indicator data.Review and resolution of client observations from GMP documentation audits.Provides quality guidance for manufacturing during GMP production. -
Quality Assurance AnalystEsoterix Nov 2013 - Feb 2016UsSupport of projects and activities related to quality assurance, control, improvement and training in a specialty clinical testing laboratory (CAP accredited, ISO 15189 certified)Deviation Investigation writing including CAPAs.Major contributor of reducing deviation backlog.Metric compilation for quality indicators.Performs quality audits for compliance with regulatory requirements and SOPs, provides recommendations for quality improvement.QA approval of deviation investigations.Quality support during client and regulatory audits. -
Quality ControlEsoterix Jun 2011 - Nov 2013Us-Provides support in the secondary review of core and clinical trials project related assay documentation and raw data.-Deviation investigation and report writing with great emphasis on root cause analysis and collaboration with senior management.-Major contributor to reduction of deviation backlog.- Quality Review of Standard Operating Procedures, Continuous Improvement documents and Validations for clinical trials and core related assays.-Trains new hire Quality Technicians
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Laboratory Analyst/Microbiologist/Qc SupervisorInstitute For Environmental Health Aug 2009 - Jun 2011-Microbiological testing of client products in an aseptic environment.-Deviation reporting writing and CAPA implementation.-Metric compiler
Frank Cooney Skills
Frank Cooney Education Details
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University Of Colorado Anschutz Medical CampusApplied Biostatistics -
Colorado State UniversityBiological Science
Frequently Asked Questions about Frank Cooney
What company does Frank Cooney work for?
Frank Cooney works for Lumos Pharma
What is Frank Cooney's role at the current company?
Frank Cooney's current role is Quality and Compliance Specialist.
What is Frank Cooney's email address?
Frank Cooney's email address is fr****@****ent.com
What schools did Frank Cooney attend?
Frank Cooney attended University Of Colorado Anschutz Medical Campus, Colorado State University.
What skills is Frank Cooney known for?
Frank Cooney has skills like Quality Control, Software Documentation, Sop, Incident Investigation, Deviations, V&v, Clinical Trials, Testing, Sas Programming, R, Statistical Data Analysis, Clinical Research.
Who are Frank Cooney's colleagues?
Frank Cooney's colleagues are David Gonzales, Zachary Danger, Peter Clayton, Monika Paluchowska, Esther Akpoigbe, Andrea Behanish, Sandra Carroll.
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