Bethany Kearney Email & Phone Number

Hamilton, New Jersey, US

Hamilton, New Jersey, US

New York, NY, US

• 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..
• 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.

Düdingen, CH

• Specialized 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 Consulting
• Supplier and site auditing
• eQMS services
• Clinical project quality services

Frankfurt, 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.

Lower 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.

Scranton, PA, US

• http://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.

Hyderabad, TS, IN

• www.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.

US

• http://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.

US

• 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.

http://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.

Bachelor Of Science (B.S.), Biology, Chemistry Minor

Diploma

Education record