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Senior Specialist - API

Job in Winslow, Kennebec County, Maine, USA
Listing for: Elanco
Full Time position
Listed on 2026-07-23
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, Production QC/QA
Salary/Wage Range or Industry Benchmark: 65000 - 90000 USD Yearly USD 65000.00 90000.00 YEAR
Job Description & How to Apply Below
Location: Winslow

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. In this role, you will be responsible for maintaining the availability of records for subsequent processes, ensuring real-time compliance, and proactively resolving bottlenecks to maintain operational momentum.

Responsibilities
  • 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 elevate immediately in the event that a record is held for any reason to prevent downstream operational impact.
Minimum Qualifications
  • Education:

    High School Diploma or equivalent.
  • Experience:

    Demonstrated experience in a process‑oriented role where being action 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.
Preferred Qualifications
  • Proficiency in SAP or similar ERP systems.
  • Previous experience working within a GMP (Good Manufacturing Practice) manufacturing environment.
Other Information
  • 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.

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Position Requirements
10+ Years work experience
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