Columbia, SC, 29240, USA
1 day ago
Quality Assurance Intern
Job Description: This internship offers a hands-on learning experience where you'll gain valuable insights into how newly developed pharmaceutical drugs transition from development to commercial distribution. In this position you will first learn how pharmaceutical drugs are initially manufactured for commercial use. Then review recent case studies to evaluate key steps in formulation, filling, and packaging to analyze at least three new drug product launches. The goal of this activity will be to identify patterns of success and challenges to present your findings in a visually engaging format (e.g., Process Map, Checklist, or Diagram). This job will also provide a unique opportunity as your analysis will be applied to a real-time Scale-Up Process Validation project midway through the internship. This is a fantastic opportunity to develop problem-solving, analytical, and industry-specific skills while gaining real-world experience in pharmaceutical manufacturing. Responsibilities: + Research & Analysis: Review industry requirements (21 CFR 211 and FDA Guidances) and apply these to recent pharmaceutical drug launches. + Process Evaluation: Analyze key steps in drug formulation, filling, and packaging to define criticality. + Collaboration: Work alongside industry professionals to gain insights into best practices and challenges in pharmaceutical production. + Process Documentation: Compile findings into a clear and structured format. + Presentation: Summarize and present findings to supervisors and team members, demonstrating an understanding of manufacturing efficiencies and improvements. Qualifications: + Progressing to bachelor degree in a Science, Technology, Engineering, or Mathematical field + Strong analytical and problem solving skills + Attention to detail + Proficiency in Microsoft Office (Excel, Word, PowerPoint) + Strong written and verbal communication skills + Ability to work independently and collaboratively in a team environment Qualifications Qualifications: + Progressing to bachelor degree in a Science, Technology, Engineering, or Mathematical field + Strong analytical and problem solving skills + Attention to detail + Proficiency in Microsoft Office (Excel, Word, PowerPoint) + Strong written and verbal communication skills + Ability to work independently and collaboratively in a team environment
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