Compliance Officer (Inspection Coordinator)

Job description

Responsible for implementing and maintaining a functional internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards. Responsibilities •Responsible for Regulatory Compliance at the plant level which includes planning and conducting internal compliance audits of all operations within the facility. •Serve as plant administrator for all company and regulatory agency (i.e. DEA, FDA) inspections. •Convey all violations to appropriate plant management/supervisory personnel via written reports and/or open discussions in audit wrap-up meetings. •Follow up on audits to assure that action plans are developed and completed in a timely fashion. •Keep current with all regulatory requirements and disseminate and interpret all regulatory requirements to plant personnel in a timely and accurate fashion. •Consult with plant personnel on regulatory requirements and compliance related topics. •Responsible for management review and associated metrics for the plant •Administrate/coordinate the plant manufacturing materials and pest control programs. •Coordinate and facilitate major plant quality improvement projects at the plant or company level. •Perform process of metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s) •Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required. •3+ years of Biopharmaceutical experience •Quality Assurance/Regulatory Affairs/Compliance experience required •Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA). •Able to demonstrate extensive knowledge of plant and company level procedures. •Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc. •Strong decision making •Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve .