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Job #03559

About our client Our client is a rapidly growing CRO that focuses on conducting research and providing resources for the development of oncology and infectious disease therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of it's employees Position Location Sr. Compliance Specialist Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform audits of subcontractors and independent audits under a contract requirement 2) Prepare or review audit reports as relevant to the activity 3) Review responses and make a recommendation for course of action 4) Review statements of work for each audit requirement when audit subcontractors are used 5) Develop and periodically evaluate auditing pool of consulting companies 6) Review technical and business proposals from audit companies 7) Draft quality agreements with outside subcontractors. Collate changes and addendums 8) Schedule periodic reviews of quality agreements between company and sites 9) Oversee reporting requirements of quarterly updates to proposed CAPA plans 10) Ensure requirements are being fulfilled 11) Schedule audit dates, which can include coordination of up to 5 or more participating parties 12) Schedule conference calls as needed to maintain effective communication 13) Identify a specific list of read-ahead documents and distribute. Assemble pre-audit packages for relevant audit attendees Requirements 1) BS in biology or related scientific field 2) Minimum of 5-7 years lead auditing experience 3) Must have knowledge of cGMP/cGLP and FDA and international regulations 4) MUST have background/experience in biologics 5) MUST have direct experience auditing animal facilities 6) Requires approximately 25% travel