Quality Assurance Associate

4 days ago


Winchester, Kentucky, United States Alltech Consulting Services Inc Full time
Job Description:

The Quality Assurance Associate is responsible for ensuring the quality and compliance of manufacturing operations for solid oral dosage products. This role involves oversight of manufacturing activities, testing of in-process and finished product samples, and maintenance of quality records.

The ideal candidate will have a strong understanding of cGMP and CFR guidelines, as well as experience in a regulated GMP manufacturing environment. A bachelor's degree in a related science or technical field is preferred, along with 2 years of prior relevant work experience.

Key Responsibilities:

  • Review and approve manufacturing batch records and testing results
  • Conduct real-time audits of manufacturing operations to ensure compliance with cGMP and CFR guidelines
  • Perform testing of in-process and finished product samples to ensure quality and compliance
  • Maintain quality records and reports, including deviation reports and CAPAs
  • Collaborate with cross-functional teams to resolve quality issues and implement process improvements

Requirements:

  • Bachelor's degree in a related science or technical field
  • 2 years of prior relevant work experience in a regulated GMP manufacturing environment
  • Strong understanding of cGMP and CFR guidelines
  • Excellent communication and problem-solving skills


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