McKesson QA Auditor in Houston, Texas
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Specialty Health, our products and services span the full continuum of specialty patient care. From the initial phases of a product life cycle and the distribution of specialty drugs, to fully integrated healthcare technology systems, practice management support, and ultimately to patient care in the communities where they live, we empower the community patient care delivery system by helping community practices advance the science, technology and quality of care.
We have a vision —that the long-term vibrancy of community care will be achieved through the leadership of physicians committed to clinical excellence and innovation, enabled by close collaboration with our organization and our deep clinical, operational and technological expertise.Every single McKesson employee contributes to our mission—by joining McKesson Specialty Health you act as a catalyst in a chain of events that helps millions of people all over the globe. You’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
Join our team of leaders to begin a rewarding career.
Thisposition is responsible for ensuring that internal departments andparticipating sites practices are compliant with Standard OperatingProcedures (SOPs), applicable federal regulations, and Good ClinicalPractices. Assists Research Quality Managerin maintenance of the quality management system related to the conduct and executionof clinical trials within IntraFUSION Research and participatingsites. Assist in continuousimprovement of processes and best practicesimplementation, while maintaining regulatory compliance, to maximizequality, productivity and efficiency between departments and sites.
Assist in the development, implementation and maintenance of the quality management system. Collaborate to develop, maintain, and manage polices, SOPs, associated processes, and procedures for the SMO, and participating sites. Use audit function to identify quality-related issues both at sites and within the central office. Reviews source documentation for adherence with Good Documentation Practices and ALCOAC standards.
Assist in preparations for regulatory inspections (FDA, etc.) and sponsor audits. Facilitates regulatory agency inspections by being an on-site presence to work directly with the inspector. Mediates as necessary and provides recommendations to the site investigator and site personnel regarding interactions with the inspector. Facilitate Sponsor audits of sites and/or corporate process audits. For Site audits provide support to site staff and auditor, either remotely or in person, during the conduct of the audit.
Reviews internal and external audit reports from corporate and site audits. Assist in writing corporate and site responses to findings from regulatory inspections, internal audits, and external audits. Works in collaboration with Research Quality Manager, department heads, and site management to create, and implement Corrective and Preventative Action plans. Monitors the execution, completion of the plans, and review of the parameters to test the effectiveness of the plan.
Participate in the design, implementation, and documentation of training requirements of corporate and site staff, based on current industry standards, new or complex government regulations, guidance and/or ICH-GCP. Perform audits/reviews of training records on policies, SOPs, and associated processes and procedures of corporate employees and communicate findings with appropriate leadership. Assist in design and implementation of education programs for corporate and site staff based on tracking and trending of audit results and findings.
Oversee and maintain electronic document repository accounts assigned to Research Quality team. This includes providing access to external auditors, troubleshooting connectivity problems, loading and emptying accounts.
Performs tracking and trending of findings/observations from external and internal audit reports. This includes site compliance audits, sponsor audits, Research Quality audits (site or central office), and data mining.
2 years audit or related experience
A minimum of (5) years of experience in clinical research to include quality and auditing experience in multispecialty disciplines.
SoCRA or ACRP certification preferred.
Specialized Knowledge/Skills –
Strong working (or thorough) knowledge of Federal Regulations and Guidances (i.e.: CFR 21) as well as GxP (GCP, GDP, GMP) as they relate to the conduct of clinical research. Requires analytical, research communication, and presentation skills.
4-year degree in business or related field or equivalent experience
Travel up to 30% - air/car
General Office Demands
Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.
We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.
But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
McKesson is an equal opportunity and affirmative action employer – minorities/females/veterans/persons with disabilities.
Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
No agencies please.
Job: Finance and Accounting
Organization: McKesson Specialty Health
Title: QA Auditor
Requisition ID: 18002842