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Job Title: QA Floor Consultant

Location: Durham, NC

Overview:

The DAP (Device, Assembly, Packaging) QA Floor Representative will provide direct quality oversight of floor operations for combination product device manufacturing. This role ensures compliance with regulatory requirements and quality standards while supporting operational efficiency in a fast-paced, high-growth environment.

Key Responsibilities:

• Provide real-time quality assurance (QA) oversight of device, assembly, and packaging operations on the production floor.
• Make informed quality decisions to resolve on-the-floor issues effectively and efficiently.
• Ensure compliance with regulatory and internal quality standards specific to combination products.
• Support deviation management, ensuring timely triaging and resolution (e.g., minor deviations closed within one week).
• Facilitate process improvements to enhance production efficiency while maintaining compliance.
• Collaborate cross-functionally with engineering, operations, supply chain, and technical services teams.
• Support qualification and training efforts to rapidly expand operational capabilities.

Qualifications:

• Bachelor's degree in a relevant field (or equivalent experience).
• Experience in quality assurance within a pharmaceutical or medical device manufacturing setting.
• Strong understanding of combination product manufacturing (e.g., prefilled syringes, autoinjectors, insulin pens).
• Ability to work collaboratively and influence teams without direct authority.
• Willingness to travel as needed to support site operations. Travel could include WI, NC, IN, and other states in US.
• Flexible schedule to support 24/7 operations as required.