Serialized Product Traceability encompasses a set of Serialization and Track & Trace initiatives aimed at securing our supply chain to ensure safe, authentic products reach every patient, every time. The Serialization Process Specialist is accountable for ensuring accuracy and completeness of all Serialization transactions as part of the serialization program at Endo USA, Inc. The individual will be part a fast-paced team seeking to comply with a rapidly evolving landscape of global serialization regulations as well as leveraging new capabilities to improve the way Endo makes and delivers products to patients. This role will interact with a wide range of business functions to manage transactions, resolve transactional errors, understand processes, improve capabilities, and deploy new technologies quickly and effectively.
This role will be accountable for responding to verification requests of data scans ensuring that verification requests are legitimate. This role will support the management of serialization efforts with our customers, internal manufacturing sites, and Contract Manufacturing Organizations (CMO’s) in a timely and professional manner.
Scope of Authority
Enterprise-wide maintenance of Serialization Activities within the Global Supply Chain function.
Key Accountabilities
Serialization
- Proactively monitor the systems daily to avoid delaying product release to market.
- Identify any gaps and suggest improvements based on industry best practices.
- Maintain procedures and compliance with serialization regulations in a timely fashion.
- Assist in investigating and verifying negative responses to salable return verification requests.
- Support the development and implementation of process and procedures to exchange serialization data with downstream partners.
- Onboard new partners and products for exchange of serialization information.
- Troubleshoot serialization related issues. Formal investigation of support issues, communication with impacted stakeholders, vendors, resolution/closure of the issue, and updating appropriate knowledge management records.
- Support evaluation and development of internal and external SOPs to ensure compliance with current and future DSCSA requirements.
- Manage master data to ensure accurate data exchange with upstream and downstream trading partners.
70%
Collaboration
- Collaborate with external Supply Chain partners (CMO's, 3PLs, Wholesalers, Customers) for real time visibility to support serialization activities.
- Communicate effectively and build cooperative and supportive working relationships across the wide range of functions involved in ensuring compliance to applicable regulations.
- Communicate and interact regularly and comfortably across various departments, from individual(s) to discuss solutions that foster strong relationships and continued success of the project.
30%
Qualifications
Education & Experience
- Bachelor’s degree in business, Supply Chain, Information Technology, or similar subject area.
- 1-3 years of relevant experience.
Knowledge
- Work experience in pharmaceuticals and/or manufacturing environments.
- Knowledge of the Drug Supply Chain Security Act (DSCSA) requirements.
- Experience using TraceLink preferable.
Skills & Abilities
- Coordinate and conduct regular stakeholder meetings.
- Track project deliverables using appropriate tools.
- Ability to identify issues and risks and, in conjunction with the stakeholders, formulate plans to mitigate risks.
Physical Requirements
- Standard office environment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.