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DSCSA Compliance Specialist

4 weeks ago

Plano, Texas, United States Maxor Full time
Job Summary:

The DSCSA Compliance Specialist will be responsible for ensuring compliance with the Drug Supply Chain Security Act (DSCSA) regulations within the organization. This role involves managing and coordinating the tracking and tracing of pharmaceutical products, maintaining accurate records, and collaborating with internal and external stakeholders to ensure the integrity and safety of the drug supply chain.

Key Responsibilities:

Ensure the organization complies with all DSCSA requirements, including product tracing, verification, and reporting.
Stay up to date with changes in DSCSA regulations and implement necessary updates to internal processes.
Maintain accurate and complete records of product transactions and movement.
Utilize electronic systems to manage data related to product tracing and serialization.
Conduct regular audits to verify the accuracy and integrity of data.
Collaborate with suppliers, manufacturers, distributors, and other stakeholders to ensure compliance and resolve any issues related to product tracking.
Serve as the primary point of contact for DSCSA-related inquiries and communications.
Provide training and support to internal teams on DSCSA requirements and best practices.
Develop and maintain documentation, including standard operating procedures (SOPs) and training materials.
Generate regular reports on compliance status, audit results, and other key metrics.
Analyze data to identify trends, risks, and opportunities for improvement in compliance processes.

Requirements:

Bachelor's degree in a related field such as Supply Chain Management, Business Administration, or a Life Sciences discipline.
Certification in supply chain management or regulatory compliance is highly desirable.
Minimum of 2-4 years of experience in compliance, supply chain management, or a related role within the pharmaceutical industry.
Experience with serialization and traceability systems preferred.

Why Maxor?

At Maxor, we foster a diverse and progressive culture that promotes a work-from-home model and a 'dress-for-your-day' approach to work attire. Our team-oriented environment encourages collaboration and innovation. We offer highly competitive compensation and comprehensive health benefits, including comprehensive mental health and wellbeing resources, nationwide Blue Cross Blue Shield PPO, company-paid basic life/AD&D, short-term and long-term disability insurance, Rx, dental, vision, other voluntary benefits, and FSA, employer-matched 401k Plan, industry-leading PTO plan, and more.