Senior Specialist - API

Position Description

As an Operations Document Flow Controller, you will be a vital part of the Operations team, ensuring that all documentation required for manufacturing processes flows seamlessly according to current standards. You will maintain the availability of records for subsequent processes, guarantee real‑time compliance, and proactively resolve bottlenecks to maintain operational momentum.

• Process Development & Optimization:
  Create, develop, and continuously improve the document flow processes within operations to enhance efficiency and ensure alignment with site standards.
• Workflow Management:
  Ensure all documentation moves through the operational lifecycle efficiently, timely, and completely, ensuring they are available for subsequent processes before they are needed.
• Roadblock Mitigation & Escalation:
  Proactively identify, track, and elevate roadblocks to processes (such as deviations, QC results, document approvals, and formulations) and work cross‑functionally to mitigate delays.
• Compliance & Real‑Time Review:
  Ensure real‑time reviews are completed, deviations are tracked and closed on time, and formulations are available to support continuous production.
• Operational Oversight:
  Actively monitor records and immediately elevate if a record is held for any reason to prevent downstream operational impact.

• Education:
  
  High School Diploma or equivalent.
• Experience:
  
  Demonstrated experience in a process‑oriented role where being action‑driven and data‑driven was critical to success.
• Skills:
  
  Significant attention to detail and the ability to influence stakeholders at all levels of the organization to maintain document flow.

• Proficiency in SAP or a similar ERP system.
• Previous experience working within a GMP (Good Manufacturing Practice) manufacturing environment.

Must adhere to biosecurity procedures, including gowning requirements and PPE.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.