Beth Schofield Email & Phone Number

Saint Albans City, Vt, Us

Swanton, Vt, Us

Dublin, County Dublin, Ie

Management-level role overseeing team of quality assurance processionals implementing systems and processes to monitor product development and commercialization processes. Lead design, management, and measurement of processes and standards for auditing and CAPA, including internal and external audit processes. Utilize audit findings to refine internal audit schedule and quality planning. Manage training and certification of internal auditors. Coach, mentor, and support CAPA and Audit issue resolution planning and project management professionals across the US. Manage data and code reviews, complaints, and tracking.

Dublin, County Dublin, Ie

Main function for role included performing Internal and external audits, including hosting successful audits.Role expanded and responsibilities increased numerous times under same title. Release Services Materials and Batch Auditor (Functional Title)o Record Review & Release of Raw Material/Batch. Complaints Specialist (Functional Title)o Evaluation & Determination of Investigation for complaints.o Writing Complaint Investigation Reports. Quality Deviation Investigator (Functional Title)o Investigation into Materials and Product Deviations.o Writing Investigation Report and Recommendation for disposition. Perrigo Quality Engineer for 3rd Party (Functional Title)o Quality / Regulatory Compliance consultant for production of liquid infant formula.o Included Audits, CAPA, Change Controls, Scorecards and Deviations. o Delivered measurable improvements in audit findings and deviations. Project Manager (Functional Title)o Served as project manager for standardization of compliance-related items.o Led cross-functional teams of 4-12. - Six Sigma Green Belt achieved - Recognized and awarded for reduction of on-hold materials.

Dublin, County Dublin, Ie

Conduct quantitative and qualitative analysis of cGMP Manufacturing Environment according to FDA, ISO, cGMP and Standard Operating Procedures. Duties included Sampling of Environment, Raw Materials and Finished Product through ISO standards and test protocols.

St. Albans, Vt, Us

Test and analyze body fluids.Operate & troubleshoot automated equipment that analyzes multiple samples at the same time.Record data from medical tests and enter results into a patient's medical record.