Quality Intern

Job Summary:

We are seeking a motivated and detail-oriented Quality Intern to join our team for the spring semester. The ideal candidate will assist in ensuring that our products/services meet or exceed industry standards and customer expectations. Under the guidance of our experienced quality professionals, the Quality Intern will gain hands-on experience in quality assurance and quality control.

Duties/Responsibilities:

• Support investigations into deviations, out-of-specification results, and non-conformances by collecting data, conducting root cause analysis, and assisting in the development of corrective and preventive actions (CAPAs)
• Participate in the review and approval of manufacturing and testing documentation, including batch records, protocols, specifications, and standard operating procedures (SOPs), to ensure compliance with regulatory requirements and internal quality standards.
• Collaborate with cross-functional teams, including manufacturing, research and development, and regulatory affairs, to address quality-related issues and implement process improvements.
• Support cGMP training initiatives by participating in training sessions and assisting in the development of training materials for employees across various departments.
• Create and maintain log books and documentation systems in compliance with cGMP requirements, ensuring accurate and timely recording of critical manufacturing, testing, and quality control data.
• Regularly review and verify entries in log books to ensure completeness, accuracy, and compliance with established procedures and regulatory requirements.
• Coordinate the archival and retention of log books and documentation records according to cGMP guidelines and company policies, facilitating efficient retrieval and audit trails.

Required Skills/Abilities: 

• Strong attention to detail and commitment to upholding the highest standards of product quality and regulatory compliance.
• Willingness to learn and develop new skills in pharmaceutical quality assurance, cGMP compliance, and related areas.
• Value patient safety and demonstrate a commitment to upholding the highest standards of product quality and regulatory compliance.
• Ability to complete a project that contributes to the understanding of pharmaceutical quality assurance, cGMP compliance, or related topics, which can also fulfill academic requirements for the intern's school program.

Education and Experience:

• Currently enrolled in a relevant field (e.g., quality management, pharmacy, pharmaceutical sciences, chemistry, biology, biochemistry, biomedical, or related disciplines).
• Sophomore, Junior, Senior, or graduate level.
• Excellent oral communication and technical writing skills.
• Microsoft word and excel experience.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 50 pounds at a time.