Merck & Co. Inc.

West Point, PA, 19486, USA

      DescriptionMerck & Co. Inc., established in 1891, is a global research-driven pharmaceutical company dedicated to putting patients first. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health.  As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.   The Site Compliance Specialist supports GMP compliance activities by participating in audits, preparing for regulatory inspections, and reviewing procedures. Specific responsibilities include, but are not limited to:
Conducting shop floor inspections, and participating in internal and divisional audits as well as pre-PAI assessments to ensure site readiness for regulatory inspections Evaluating manufacturing/packaging/laboratory facilities to assure compliance with internal, FDA and other regulatory agency requirements Facilitating and/or providing support for regulatory inspections by preparing daily minutes during the inspection, assisting the regulatory inspectors with obtaining required information, and coordinating the preparation of responses Providing experienced and mature judgment when performing special projects and investigations assigned by the Franchise Leader/Manager Coordinating the tracking of divisional audit commitments Performing and/or coordinating gap analyses for approved divisional guidance documents, regulatory guidance documents, and quality bulletins to ensure internal compliance Updating and/or reviewing Standard Operating Procedures and departmental written procedures for accuracy, consistency, and compliance with current GMPs and FDA commitments Actively conducting regulatory surveillance Training entry level personnel Understanding and conforming to all changes in federal and other regulatory agency re

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