What are the responsibilities and job description for the Compliance & Regulatory Operations Specialist position at Coulter Services?
Role: The Quality & Regulatory Operations Specialist supports compliance and safety programs at a pharmaceutical distribution facility.
Responsibilities
Responsibilities
- Monitor compliance programs and collaborate with management on regulatory issues
- Review and release controlled substance orders, ensuring completeness
- Maintain regulatory records and safety/security files
- Conduct internal audits for agencies like DEA, DOT, OSHA, and PDMA, and prepare reports
- Investigate compliance incidents and work-related injuries, identifying security vulnerabilities
- High school diploma or equivalent
- Over 2 years of experience in compliance, regulatory, or distribution environments
- Knowledge of federal, state, and local regulations
- Strong communication, interpersonal, and organizational skills
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to interpret regulatory requirements and implement audit processes