Bethany Kearney Email and Phone Number
Bethany Kearney's Location
Kennebunkport, Maine, United States, United States
Bethany Kearney's Contact Details
Bethany Kearney work email
- Valid
Bethany Kearney personal email
n/a
Bethany Kearney phone numbers
About Bethany Kearney
Worked to transform companies by building and enhancing quality systems to meet regulatory requirements, future portfolio expansion, achieving certifications, satisfying required inspections and meeting proactive quality goals. Certified by the American Society of Quality as a Certified Quality Auditor. Currently as the Director of the Mid-Atlantic Region Quality Association, of the Society for Quality Assurance (SQA), is a member of American Society of Quality (ASQ), and Regulatory Affairs Professional Society (RAPS).
Bethany Kearney's Current Company Details
Bethany Kearney Work Experience Details
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Director Of Services EnablementHoneywell | Life Sciences Jun 2022 - PresentHamilton, New Jersey, Us
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Industry Best Practices Coe, Professional ServicesHoneywell | Life Sciences Dec 2019 - Aug 2022Hamilton, New Jersey, Us
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Chief Quality OfficerQacanna Sep 2019 - PresentNew York, Ny, Us -
Quality Management ConsultantBethany Kearney Llc Jun 2019 - Present• Enhancement of quality management systems for clients to prepare to FDA, ISO and MDR inspection/certification readiness. Providing active continuous quality improvements, process mapping and best practice training. Creation and evaluation of risk management programs, associated events, noncompliance and CAPAs within the Design History File. • Offering unique eQMS consulting services to ensure limited disturbance to operations during the transition of eQMS service providers or from a paper to electronic QMS. Customized eQMS review services to expedite the software selection process.
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Quality Management ConsultantConfinis Cpm Ag Dec 2018 - PresentDüdingen, ChSpecialized in Clinical Quality Management• Documentation of project quality, review and audit processes for each clinical project team. • Documentation of inspection and root cause analysis for project deviations, clinical site evaluation results and continuous improvement initiatives.• Evaluation and qualification of electronic tools for the quality management system as well as clinical project management. • Design quality surveillance processes for review of data, safety event reporting, clinical study reporting. -
Quality Management And Audit ConsultantIndependent Consultant Jan 2019 - PresentQuality Management Consulting• Supplier and site auditing• eQMS services• Clinical project quality services
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Quality Solutions Expert/AuditorChemsquare Gmbh Jun 2019 - Dec 2019Frankfurt, Hesse, De• Ability to contract and expedite the audit of key suppliers, on site audit support and clinical site audits and bring non-compliant findings to resolution. -
Director, Global Quality ManagementClinlogix, Llc Sep 2016 - Dec 2018Lower Gwynedd, Pa, Us• Responsible for developing, leading and implementation of the annual Quality Management program for the Company.• Ensure that Company SOPs, GCPs, JGCPs, and ICH guidelines are adhered to; contributing to training activities and process improvement as needed.• Actively support implementation and maintenance of ISO 9001 certification.• Develops, performs, manages and reports quality assurance activities • Responsible for overseeing, managing and reporting ISO Standard metrics, periodic and annual reports; including quality trending reports • Reports the status of the quality levels of staff, systems and production activities.• Presides and assists over the audit process, quality events, queries, and complaints and manages the resolution using improvement programs.• Ensures clinical processes and project execution are conducted in accordance with SOPs, guidelines, regulations and according to the protocol. • Participate with compilation and preparation of materials for submission to regulatory agencies. -
Director Of Research ComplianceThe Commonwealth Medical College (Tcmc) Mar 2015 - Sep 2016Scranton, Pa, Ushttp://www.tcmc.edu/• Support the mission of The Commonwealth Medical College (TCMC) with regards to upholding the highest standards of research integrity and compliance.• Guiding researchers and ensure compliance to federal, state and local regulations and TCMC policies. -
Senior Associate, Development Quality AssuranceDr. Reddy'S Laboratories Dec 2012 - Mar 2015Hyderabad, Ts, Inwww.drreddys.com• Provide Quality Assurance support for drug substance and biopharmaceutical formulations currently in development throughout the INDA, ANDA or NDA submission process.• Execute Quality by Design attributes into drug development process prior to each phase of submission. • Evaluate contract manufacturing, research and clinical organizations to support projects for Dr. Reddy's and Promius Pharma.• Provide support for implementation of Quality System across worldwide Development Quality System including procedure initiation and training execution. -
Quality Laboratory PlannerMcneil Consumer Healthcare Jul 2010 - Dec 2012Ushttp://www.mcneil-consumer.com/•Schedule daily tasks for 40 Scientists in an Analytical Laboratory including product release, raw materials, marketed stability studies, complaints, investigational protocols and calibrations.•Project management support for laboratory construction, decommissioning and commissioning projects.•Support regulatory agency audits including ISO14001, DEA and FDA per Consent Decree requirements.•Management of inventory for laboratory operations including chemicals, equipment and supplies. -
Scientist, Marketed Product Stability CoordinatorMcneil Consumer Healthcare Oct 2005 - Jul 2010Us•Put up and pull studies on MPS to support yearly commitments at the appropriate intervals.•Support MPS program by authoring Annual Product Reviews.•Facilitate new product method transfers including method analysis, verification, SOP revision and training of Analytical Scientists.•Author procedural documents as per the Johnson and Johnson Standards, Quality Guidelines, USP and ICH guidelines. •Liquid and solid dose bench chemistry including HPLC, UPLC, dissolution, TLC, IR spectroscopy, UV spectroscopy particle size, pH, density and viscosity.
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Assistant Field ResearcherAcademy Of Science, Philadelphia/ National Science Foundation Jun 2004 - Aug 2005http://tardigrade.acnatsci.org/Collected and examined Tardigrade specimens from the United States as well as China. Research included a paper published in the Pennsylvania Academy of Science Journal and an educational website.Research was funded by a 4 year grant by the National Science Foundation with support from the Academy of Science in Philadelphia, Academy of Science in China, The University of Wuhan and Chestnut Hill College.
Bethany Kearney Skills
Fda
Pharmaceutical Industry
Quality Assurance
Gmp
Hplc
Quality Control
Sop
Project Management
Change Control
Quality System
Lims
Validation
Laboratory
21 Cfr Part 11
Regulations
Technology Transfer
Drug Development
Standard Operating Procedure Author/edit
Capa
Regulatory Affairs
Green Belt
Formulation
Glp
Biotechnology
Clinical Trials
Good Clinical Practice
Gxp
Analytical Chemistry
Software Lifecycle
Usp
Laboratory Safety
Cross Functional Coordination
Technical Project Leadership
Ii And Waters Lc Millennium Chromatographic Software
Laboratory Information Management Systems
Public Speaking
Quality Process Development
Ind
Laboratory/manufacturing And Hazardous Material Safety Training
Compliance Management
Human Subjects Research
Iacuc
Irb
Qualification
Iso Certification
Computer System Validation
Supplier Qualification
Gamp
Bethany Kearney Education Details
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Chestnut Hill CollegeChemistry Minor -
Wallenpaupack Area HsDiploma
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Owen J. Roberts Hs
Frequently Asked Questions about Bethany Kearney
What company does Bethany Kearney work for?
Bethany Kearney works for Honeywell | Life Sciences
What is Bethany Kearney's role at the current company?
Bethany Kearney's current role is Quality Management Professional.
What is Bethany Kearney's email address?
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What is Bethany Kearney's direct phone number?
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What schools did Bethany Kearney attend?
Bethany Kearney attended Chestnut Hill College, Wallenpaupack Area Hs, Owen J. Roberts Hs.
What skills is Bethany Kearney known for?
Bethany Kearney has skills like Fda, Pharmaceutical Industry, Quality Assurance, Gmp, Hplc, Quality Control, Sop, Project Management, Change Control, Quality System, Lims, Validation.
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