Lisa Pomeroy Email & Phone Number

Limerick, Pennsylvania, Us

Manage all Quality Assurance activities. Responsible for handling internal compliance and implementation of a quality system for all laboratory divisions. Review, update and create laboratory and animal care SOPs. Train staff on SOPs and safety procedures. Perform internal quality audits. Conduct and document CAPA investigations. Work with USDA, DEA and other federal agencies to obtain or renew required licenses and certifications and complete on-site audits. Conduct, review and approve vendor qualification surveys for suppliers. Respond to requests for vendor qualification surveys from customers. Ensure all work carried out onsite is in compliance with the required standards, conforming to company policies, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.

Limerick, Pennsylvania, Us

Manage all Quality Assurance activities. Responsible for handling internal compliance and implementation of a quality system for all laboratory divisions. Review, update and create laboratory and animal care SOPs. Train staff on SOPs and safety procedures. Perform internal quality audits. Conduct and document CAPA investigations. Work with USDA, DEA and other federal agencies to obtain or renew required licenses and certifications and complete on-site audits. Conduct, review and approve vendor qualification surveys for suppliers. Respond to requests for vendor qualification surveys from customers. Ensure all work carried out onsite is in compliance with the required standards, conforming to company policies, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.

Audited EDC and IRT studies and core product software validation. Ensured internal standards were in conformity with applicable regulatory agencies and guidance (GCP and GDP). Conducted internal audits of company policies and procedures. Submited written audit reports to the study personnel and management. Identified compliance gaps and provided support and suggestions for remediation. Conducted vendor audits. Served as SOP Manager. Facilitated the identification, development and revision of policies, SOPs and work instructions. Authored standard operating procedures and work instructions (GDP and QA). Provided training and guidance to staff regarding compliance and interpretation of policies, SOPs and work instructions. Co-host/facilitated client audits. Maintained QA records and reviewed study documentation in preparation of client audits. Worked with the audit team in responding to client audit observations.

Reviewed protocols, raw data and draft study reports to assure accuracy and adherence to procedures. Submitted written audit reports to the study director and management. Maintained Quality Assurance Unit (QAU) study files. Conducted periodic facility inspections to ensure GLP compliance. Authored SOPs (e.g. QAU, training, software validations). Provided compliance support for electronic records systems. Developed and managed the GLP training program. Managed Personnel Qualifications Files. Served as SOP Manager. Provided assistance in the event of a regulatory agency compliance inspection. Worked closely with team members across sites for business process improvement projects

Paris, France, Fr

Performed a wide range of preclinical safety and reproductive toxicology studies according to SOP and GLP guidelines. Utilized various dosing and blood collection techniques, technical procedures and reproductive tox procedures. I was a Study Director for a non-GLP study. I wrote study plans and amendments according to ICH and GLP guidelines. I was responsible for purchasing supplies for all studies, serving as User Manager for two data collection systems, mentoring new employees and reviewing study raw data and reports.

Brentford, Middlesex, Gb

Worked in the Induced Mutant Resource Group managing transgenic mouse colonies. Performed breeding and weaning, maintained accurate records and worked closely with investigators to fill requests. Trained in cesarean rederivation techniques, tail snipping and ear notching. Performed sentinel bleeding and health monitoring, dog sling training, dog table training and basic animal husbandry.