Tracy Staton Email & Phone Number

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Lead and co-lead internal and vendor computer system audits related to GCP/GLP/GVP systems including but not limited to pre/post audit meeting, agenda, partnering with key stakeholders, review of legal contracts and vendor/internal processes ensuring systems are developed, validated, managed and controlled based on applicable regulations and guidelines.• Manage audit related observations and CAPAs.• Work closely with Digital Technology department, system owners and business owners to effectively and efficiently implement new systems, system upgrades, or system modifications.• Participate in the change control program for modifications to qualified systems.• Review and approve computerized system related documents and procedures.• Support regulatory agency inspections as needed.• Participate and actively engage in strategic initiatives which require CSV support.• Provide support and input into the full CSV and SDLC program.• Contribute in the continuing development of a quality culture at Moderna.

Morrisville, Nc, Us

• Significant expertise in GxP requirements and extensive experience in the conduct of various audit types• Perform audit responsibilities as defined for Sr. Auditor with a higher level of proficiency• Expertise in the use of computerized systems in clinical trial processes• Expert knowledge in Quality Management Systems• Critical thinking skills and forensic auditing approach• Work directly with Executive Leadership Team regarding audit outcomes and quality risk management• Lead and assist departmental development initiatives• Provide leadership and mentoring to less experienced auditors

Morrisville, Nc, Us

• Plan and conduct audits of software/computerized systems used in the conduct of clinical trials, including Late Phase/Commercialization• Conduct internal process audits and computer system validation audits• Conduct audits of software vendors• Participate in collaborative audits with Clinical QA• Perform For Cause Audits• Organize and communicate audit results/risks to Executive Management and Clients• Collaborate with Vendor Management on Quality and Data Integrity Risks associatedwith Software Vendor products and services• Write audit reports, audit response review/acceptance and follow-up CAPAs to closure• Advise Operational Business Partners on Quality Issues and Data Integrity Risks• Assist in regulatory and client inspections• Write and Review SOPs• Mentor and Train less experienced auditors

Durham, North Carolina, Us

• Plan and conduct independent Early Clinical Development audits• Assess compliance with ICH GCP guidelines, FDA GCP Regulations, CLIA standards, USP 797 and Quintiles SOPs• Host customer Audits• Host and participate in regulatory inspections (i.e. KDHE, CLIA and FDA)• Prepare and distribute reports of findings to management, operations and customers• Create and deliver regulatory training to operational staff• Consult in interpretation of regulations, guidelines, policies and procedures• Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies• SOP reviews• Assist operational teams with Root Cause Analysis (RCA), CAPA plans and Quality IssuesSkills-Proficient with SharePoint, Excel, Word and Trackwise-Strong verbal and written communication-Creative thinker and problem solver

Kansas City, Ks, Us

• Develop, implement and maintain internal and external auditing and quality programs• Direct and conduct audits including: computer system validations, bioanalytical method validations, non-clinical studies, in-process, facility and vendor• Provide leadership and guidance toward compliance with: FDA GLP 21 CFR part 58 and Part 11 EPA GLP 40 CFR part 160 and 792 OECD GLP, Series on Principles of GLP and compliance monitoring ENV/MC/CHEM(98)17 Japan MHLW ISO standards• Prepare reports and consult with clients and vendors regarding quality expectations• Write facility SOPs and Quality Manual• Provide training on GLP regulations and management expectations for quality• Participate on cross departmental teams and Management team• Notify executive management of quality/regulatory expectations and industry trends in qualityManagement/Supervision:• Manage staff of 5 auditors• Manage departmental budget and scheduling• Manage staff development and competency • Direct recruitment of employees• Set and track progress toward departmental goals• Assure all audits and inspections are conducted and reported as scheduled

GMP auditsIACUC member

Burlington, North Carolina, Us

-Organized speciments for CBC-Performed sedimentation rates and retics

Columbia, Mo, Us

Research Assistant, Department of Veterinary Medicine-Conduct research for Equine Endometrial Periglandular Fibrosis study-Operate Immunoanalyzer-LSC Counts-Miscellaneous tasksResearch Assistant, Department of Ruminant Nutrition-Sample/Data collection-Bovine blood, rumen and milk sample collection-Wet/Dry weights on feed-Protein analysis-Other tasks as directed