Senior Specialist – Serialization Operations Americas/Spécialiste principal; e Opérations de Sérialisation, Amériques
Organon CanadaPosition: Senior Specialist – Serialization Operations Americas/Spécialiste principal(e) – Opérations de Sérialisation, Amériques
Location: Kirkland
Secondary Language(s)
Job Description Le poste
Relevant du/de la Responsable de la sérialisation au sein du Centre d’excellence mondial en sérialisation, la personne retenue agira à titre de principal point de contact et d’expert(e) de la matière (
...
SME) pour le soutien à la sérialisation et l’escalade des incidents au sein de la région des Amériques.
Job Description The Position
Reporting into the Serialization Lead in the Global Serialization Centre of Excellence team, the successful candidate will act as a key point of contact and SME for serialization support and issue escalation within the Americas region.
Responsibilities
• Oversee inbound logistics and serialization data flow from manufacturing sites to Organon’s third-party logistics (3PL) provider, ensuring EPCIS compliance ahead of product receipt
• Gather and document serialization requirements for new markets
• Execute and/or participate in project teams in design, build, and deployment activities
• Contribute to project impact assessment and scoping
• Act as a key contributor to new product launch initiatives by providing serialization expertise and supporting operational execution across impacted markets
• Liaison for Organon’s 3PL provider, reviewing and monitoring customer exceptions to ensure timely resolution and service compliance
• Collaborate with 3PL partner to maintain operational compliance, drive process improvements, and ensure adherence to customer and company requirements
• Utilize Verification Router Service (VRS) to assess and validate suspect product, partnering with Quality to investigate issues, determine root cause, and support disposition decisions to ensure compliance and product integrity
• Contribute as a key team member in onboarding Contract Manufacturing Organizations (CMOs), supporting cross-functional coordination to ensure alignment with quality, compliance, and operational requirements
• Process xml messages via the Advanced Track & Trace Cockpit
• Utilized the Integration Control Hub (ICH) to monitor and reprocess message flows, ensuring accurate data exchange and timely resolution of errors
• Create shipping and receiving events
• Write standard operating procedures and work-step instructions
• Collaborate with Business Technology (BT) to support serialization activities, ensuring system accuracy, data integrity, and compliance with traceability requirements
• Serve as a resource for team members, providing guidance on processes and supporting questions related to daily activities
• Actively search for process efficiencies in the team
• Act as backup support for team members during absences, covering Master Data, reporting, and daily business activities to ensure continuity and accuracy
Required Education, Experience & Skills
• Minimum of 4 years of relevant work experience i.e. Supply Chain Management, Plant Operations, Distribution, Logistics, Regulatory etc.
• Minimum of 2 years experience working with Serialization processes and data requirements
• Strong knowledge of Pharmaceutical Serialization, GS1 Standards and related technologies (EPCIS)
• Knowledge of Pharmaceutical Track and Trace regulatory reporting requirements
• Knowledge in GS1 standards (GTIN, SGTIN, GLN, SGLN, SSCC, GCP)
• Business process knowledge on pharmaceutical products packaging, aggregation, barcode printing and verification
• Good experience of working with SAP ATTP integration with SAP ECC, packaging line management solution and SAP ICH
• Demonstrated ability to align, lead and drive change activities across global and/or cross-functional teams towards a common goal. A strong appreciation that the best results come from the combined efforts of diverse teams and shared perspectives.
• Strong oral and written communication skills in English with a proven ability to organize business process…