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Job #03116

About our client Our client is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune and infectious diseases. Position Location Compliance Audit Specialist Bloomsbury, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan, perform and document GCP audits of investigational sites 2) Participate in the client’s clinical trials, CROs and the client internal systems within Product Development 3) Report audit findings to the client’s Management Team to keep them apprised of the level of GCP compliance at the clinical sites, CROs and internal departments at the client's end 4) Compile a list of corrective actions to appropriate client staff or CRO staff 5) Monitor the list through completion of the corrective action plan, abiding by the client SOPs and applicable regulations and guidelines 6) Review, coordinate and file records 7) Keep abreast of current industry practices and all governing regulations 8) Author and review client SOPs 9) Perform all activities as per client SOPs and GCP 10) Serve on project teams (as required) 11) Perform other tasks and projects as assigned Requirements 1) BS or MS in a scientific discipline or allied health profession 2) GLP or GCP compliance experience 3) Willingness to travel (up to 30% or may be more during periods of high activity)