Job Title: Associate Quality Assurance

We are seeking a dedicated Associate Quality Assurance professional to join our team on a 6-month contract. This role requires a commitment to working from 2 pm to 11 pm, with flexibility for potential shift changes. The position is located onsite five days a week in Holly Springs, NC. The successful candidate will support the inspection, sampling, and testing of raw materials at our North Carolina site, ensuring compliance with cGMP manufacturing standards.

• Inspect materials such as biobags, tubing, filters, and other components to meet inspection-related specification requirements and master inspection characteristics.
• Remove samples from containers of media and chemicals to facilitate testing.
• Utilize RAMAN technology with TruScan equipment to identify chemicals.
• Ensure inspection sampling results are detailed and compliant with written procedures and cGMP requirements.
• Document inspection sample and test results accurately in the system.
• Assess characteristics that could impact product quality according to procedures.
• Determine the color of components to match required attributes.
• Support inspection readiness activities and continual improvement initiatives.
• Assist in prioritizing and scheduling tasks for area management.
• Serve as a trainer for tasks related to raw material inspections, samples, and testing.
• Own controlled documents for the area, including SOPs and FORMs.
• Initiate and manage deviation records and CAPAs related to events and projects in raw material inspections, samples, and testing areas.
• Provide QA oversight to the Warehouse, ensuring adherence to GMP regulations.

• Quality assurance experience
• Understanding of GMP regulations
• Proficiency with RAMAN technology
• Experience with single-use inspection
• Gowning experience

• High school diploma or GED with 2 years of work experience, or
• Associate's degree with 6 months of work experience, or
• Bachelor's degree

This position requires working onsite from 2 pm to 11 pm, five days a week in a GMP-compliant environment. The role involves using specialized technology and equipment, with an expectation for strict adherence to safety and quality standards.

This is a Contract position based out of Holly Springs, North Carolina.