Clinical Qa Assurance Specialist / 08-5062
sanofi pasteur (Allentown, Pennsylvania)

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Sanofi Pasteur in the USA is a leader in the research, development, manufacture, marketing and sales of vaccines and immunological products because here we clearly see a better tomorrow for all mankind. We have a wide range of vaccines that protect against 20 diseases, but we believe there is still much work to be done. On every continent there exists viruses and bacteria, and we won’t rest until they are eradicated and all people can live healthy, full lives. We’re confident we can achieve our goals. As a subsidiary of Sanofi Aventis, the global pharmaceutical corporation, we have access to the resources needed to continue our boundary-breaking innovations far into the future. Our US site is located in Swiftwater, Pennsylvania, among the scenic Pocono Mountains, sanofi pasteur is housed in state-of-the-art facilities on a 269-acre campus. It is here that our multidisciplinary teams of 1900+ professionals work together to develop and provide new and improved immunological products. Our company is comprised of three global functions: Research & Development, Industrial Operations, and Commercial Operations, as well as seven support functions: Communications, Corporate Development, Finance and Purchasing, Human Resources, Information Solutions, Legal and Corporate Affairs, and Public Policy. For those who wish to make a difference in the world by aiding in the development, production or marketing of vaccines that are critically important to public health, sanofi pasteur offers superb opportunities. Our modern research, production and administrative facility attracts exceptional talent from businesses and universities around the world. Our location offers our people the best of outdoor living close to the cultural, culinary and recreational attractions of Philadelphia and New York City. sanofi pasteur US is a place for those who desire a challenging and rewarding career without compromising their quality of life. If you have the passion, desire, ambition, vision and talent we’re looking for, we invite you to explore our opportunities and to apply online at: www.sanofipasteur.us

Position Description:

To facilitate the implementation and conformance to GCP Regulations through the audit process by reviews of clinical sites, documents, data, and systems. Report any non-compliance identified to appropriate personnel and follow-up on any corrective and preventative action listed. Protect the rights and safety of research subjects. Promote the quality collection, recording and analysis of study data and also support the accurate reporting of data in accordance with local and international regulations. Provides clinical team with quality advice regarding design of protocol at it's early phase, and through assisting the clinical team in problem solving quality issues. Conducts vendor audits as needed. 1)GCP and Regulatory Awareness - Provide and document GCP training and interpret and advise the company regarding GCP issues/questions. Participate in post-inspection activities and assist clinical sites in management of site regulatory inspections. Contribution to the company is good knowledge base of regulatory and GCP requirements. 2)Clinical Trial Associated Audits - Perform audits of clinical sites, databases, trial master files, documentation and vendors with senior auditor, possibly as lead auditor. Contribution to the company is the assurance of data integrity, and assurance of conformance to regulations and company SOPs. 3)Internal System/Process Audits - audits of internal departmental processes. Interview of personnel with review of documentation, data, and a "walk through" of the process. Contribution to the company is prospective preventative or corrective actions, risk assessments, and the assurance of conformance to regulations and company SOPs. 4)Audit Report Generation - Identify non-compliance with regulatory regulations, procedures and GCP's. Include recommendations for corrective actions and follow-up of internal and external corrective and preventative actions. Contribution to the company is notifying sanofi pasteur personnel of areas of non-compliance as to improve the clinical research being performed. 5) Member of a Clinical Team - Participate in clinical team meetings. Communicate the project specific audit program and provide study specific training. Also, investigate study specific non-compliance issues. Contribution to the company is good knowledge base of regulatory and GCP requirements and assurance of data integrity, and assurance of conformance to regulations and company SOPs. Position does not have direct management of personnel. We are an equal opportunity employer M/F/D/V

Qualifications:

Bachelor's degree in science, preferable in biology, chemistry, nursing, pharmacy or other medical field or equivallent experience. 1 - 2 years experience in clinical research (i.e. Data Management, Biostatistics, etc). Previous QA experience preferred but not required. Demonstrated experience with good clinical practices, clinical research, healthcare, science, international regulations and vaccine products. Able to travel domestically and internationally approximately 25-50% of the time.