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  • Gcp Auditor

    Forest Laboratories, Inc.Jersey City, NJ

    Job #109112457

  • The Forest Research Institute (FRI)a wholly-owned subsidiary of Forest Laboratories, Inc.drives the scientific research and development behind Forests top-quality therapies that help people lead healthier, more fulfilling lives. With operations in Jersey City, NJ and on Long Island, plus clinical trial personnel across the country, the Institutes highly skilled professionals enable Forest to license compounds at virtually any stagefrom preclinical development to products that are ready for FDA reviewand then complete the development and regulatory work to successfully bring vital new therapies to market. Each of Forests more than 5,000 employeesincluding our 1,000 person strong Research Institutecontributes to our quest to deliver quality products with entrepreneurial spirit, integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest. Position Description Our Jersey City, NJ office has an exciting opportunity available in our Quality Assurance Department as a GCP Auditor. The main responsibility of this position is conducting internal and external GCP/GLP Compliance auditing activities. The role is approximately 95% GCP and 5% GLP. This position reports into the Sr. Manager, GCP/GLP Compliance and does not have any direct reports. You will be working within a best-practices environment and be afforded training opportunities, which will allow you to stay current on the latest trends and technology in the industry. Main areas of responsibility: Conducts document reviews/audits of informed consents, clinical study reports, regulatory submission documents etc. Conducts data review/audits of patient data listing etc. Represents the GCP/GLP Compliance group at clinical team and scheduling meetings providing input and guidance. Conducts external field audits at clinical investigator sites, CROs, etc. as lead auditor or support staff. Conducts presentations on GCP/GLP topics at Forest sponsored functions including investigator or monitor meetings. Provides auditing support to regulatory inspection activities and internal audits of Forest systems / processes. Conducts department research on current regulatory activities positions affecting GCP/GLP activities, policies and procedures. A minimum of 20% Travel / Field work is required to domestic and international locations in support of audit activities. Position Requirements Minimum Qualifications to be consisdered for this position: BA or BS in the Life Sciences orrelated field. 3 + QA experience with GCP Auditing. Knowledge of GCPs and their application and role that that the Quality/Compliance group plays in supporting drug development. Demonstrated ability withcommunication and presentation skills to promote a common understanding of quality and compliance issues associated with a specific project. Demonstrated ability to meet deadlines. Ideally candidates will also have: Strong attention to detail. Exceptional problem solving skills. Demonstrates basic coaching and training skills when working with colleagues. Strong communication skills and ability to recognize and address sensitive/complex situations. Demonstrated ability to ensure written word is consistent with verbal communications.

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