The compliance manager will assure compliance with all local, state, federal and FDA regulations. Will set and maintain appropriate policies and procedures to assure conformance with all cGMPs.
Responsibilities will include: • Audit procedures Responsibilities: • Monitor the shipment of controlled substances to ensure that forms have been received or sent. • Will perform audit to ensure that controlled substances are stored handled and processed in compliance with the DEA requirements. • Perform customer and regulatory audits on an as needed basis. • Develop systems for use to ensure regulatory compliance with all DEA regulations. • Review regulatory documents to ensure compliance with FDA requirements and procedures. • Perform vendor (suppliers or contract laboratory) and internal audits to assure quality systems are in place for compliance to cGMPs as directed by the Director of Quality. • Provide assistance to Quality Assurance as needed.
• Minimum of 7 years of pharmaceutical experience. • Minimum of 5 years of Quality experience. • DEA experience helpful.
Must have a thorough knowledge of: • cGMP GLP and DEA regulations • Technical report writing along with good oral communication skills
• EDUCATION: B.S. / M.S. in Chemistry or other Physical Science fields.
• JOB DURATION: This job is full time and long term