Documentation Specialist PATDC
Listed on 2026-06-03
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Overview
Are you quality-minded, structured, and comfortable working across cultures and functions? Client is looking for a motivated and detail-oriented professional to join our Labeling & Packaging Material team in Carpinteria for a one-year temporary position.
The Position
In this role, you will support and drive the implementation of label and (IFU) updates for In Vitro Diagnostic (IVD) products, ensuring timely and compliant execution of all activities. This will be done in close collaboration with cross-functional teams based in both the US and Denmark.
You will be organizationally part of the Labeling & Packaging Material team, which currently consists of 10 employees in Denmark (including the hiring manager) and 1 employee in the US.
Responsibilities- Coordinate implementation activities related to label and IFU updates in close collaboration with teams in Carpinteria and Glostrup, Denmark
- Act as a key point of contact across multiple functions, including project managers, Label Subject Matter Experts, production, procurement, and external partners
- Manage contact with external suppliers, such as translation vendors and IFU print providers
- Update Raw Material Specifications (RMSs) related to IFUs
- Ensure that project deliverables are completed in alignment with agreed project plans and timelines
- Register work time for cross-charging in time-keeping system
The ideal candidate will have:
- 1 to 3 years of experience in document control, quality assurance, or regulated environments
- Intermediate to advanced skills in Microsoft Word and Excel
- High school diploma or GED
- Strong attention to detail and organizational skills
- Strong communication skills, with the ability to coordinate effectively across multiple functions and in a cross-cultural environment
- A reliable, structured, and adaptable work approach, with a consistent ability to meet deadlines
- Experience with Agile or product lifecycle/document management systems (preferred)
- 1-year contract position with an immediate start date preferred
- An independent role within a highly collaborative and international team environment
- Engagement with regulated IVD products that contribute to improving quality of life globally
- A professional organization with a strong commitment to quality, compliance, and continuous improvement
- Structured onboarding supported by experienced colleagues, ensuring training in systems, processes, and role-specific responsibilities
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