Analyst, DSCSA Compliance

Job summary:

As an Analyst, Track & Trace: DSCSA Compliance, you will play a crucial role in ensuring compliance with the Drug Supply Chain security Act (DSCSA) regulations related to serialization and traceability. You will work closely with cross-functional teams to implement and maintain serialization processes, safeguarding the integrity of our pharmaceutical supply chain. This position requires a good understanding of DSCSA requirements and a strong analytical mindset.

Primary responsibilities:

• Conduct investigation and resolution of serialization-related issues, including discrepancies, errors, and system malfunctions on inbound and outbound of pharmaceutical products
• Perform serialization activities for product received with no data or partial data
• Assist with the collaboration with BioCare IT, SAP ICH, and 3^rd party support teams to implement serialization systems and processes in accordance with regulatory requirements
• Assist with serialization onboarding activities with upstream supply chain partners to establish system connectivity (manufacturers, suppliers)
• Assist with serialization onboarding activities with downstream supply chain partners to establish system and/or portal connectivity (customers)
• Perform serialization testing, validation, and documentation with upstream and downstream supply chain partners to ensure serialization systems and processes operate accurately and reliably
• Maintain serialization data, including product identifiers, transaction history, and transaction information, to facilitate product tracking and tracing
• Conduct regular quality checks to ensure accurate serialization data and system functionality
• Maintain documentation of serialization processes, procedures, and compliance records
• Assist in training and support on serialization best practices and compliance requirements
• Stay current with changes in DSCSA regulations and industry best practices
• Follow compliance with DSCSA regulations related to serialization and traceability for pharmaceutical products
• Generate reports on serialization activities and compliance status for internal and external stakeholders
• Possess high motivation, enthusiasm, and dedication to our team and customers
• Deliver quality customer service to all team members, customers, and stakeholders
• Perform all assigned duties in keeping with the Enterprise’s core values, policies, and all applicable regulations
• Bring any compliance issues to the attention of management
• Perform all other duties as assigned by management

Required competencies, knowledge, skills, and abilities:

• Strong organizational and project management skills
• Strong analytical mindset
• Experience with software systems (experience with serialization software is a plus e.g., SAP ATTP, TraceLink, rfXcel, LSPedia)
• Ability to work collaboratively in cross-functional teams
• Proficient computer skills
• Strong attention to detail and accuracy
• Proficient in Microsoft Office products
• Ability to organize, prioritize, and execute a variable workload and multiple priorities
• Ability to maintain confidentiality, high integrity, respect, flexibility, service excellence, and teamwork
• Ability to provide high levels of customer service and work effectively with all levels of staff and management
• Ability to work independently and in a team environment
• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities
• Must be able to pass a drug test and background check aligned with state and federal laws and regulations

Required certifications, licenses, education, and experience:

• Bachelor’s degree in related field or related field equivalent experience
• Knowledge of DSCSA regulations and serialization requirements

Preferred education, competencies, knowledge, skills, and abilities:

• Knowledge of pharmaceutical industry practices and supply chain processes is a plus
• Good writing, grammatical and editing skills
• Good communication and organizational skills
• Critical thinking skills
• Commitment to continuous improvement with demonstrated success in leading and influencing team members
• Proactively identifying potential issues to prevent their occurrence

Physical demands and work environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods sitting at a desk and working on a computer and/or phone
• Visual acuity to accurately read small print in contracts, RFPs and other documents
• Ability to stand, walk, bend, squat, stretch, kneel, reach, grasp, and pinch
• Ability to stand or walk in the warehouse environment for prolonged periods of time
• Physical ability to occasionally lift, carry, push, and pull up to 40 pounds