Intern - QA Patient Safety

About Tolmar

Do you want to learn new skills, explore pharmaceutical research and manufacturing, network with experts, and build a resume that opens doors? Join us to launch your career. We'll support you with training, employee connections, and our shared vision for specialty pharmaceuticals.

Tolmar, Inc. is a fully integrated pharmaceutical company based in Colorado that develops, manufactures, and globally distributes branded and generic prescription pharmaceuticals in the areas of urology, oncology, and dermatology. Tolmar is a leader in the development and manufacturing of specialty injectable products such as ELIGARD and FENSOLVI, not to mention our extensive line of generic prescription dermatologic applications.

Passion guides our commitment to providing the highest level of support to the health care providers and patients within the disease states that our products treat. Our highly experienced commercial leadership team and specialty sales force embody dedication with purpose. Tolmar is dedicated to advancing our pipeline of products and expanding our portfolio to serve important patient medical needs.

This internship provides hands‑on experience in Quality Systems & Compliance (Quality Assurance), exposure to real‑world problem‑solving, and professional development opportunities. Under general supervision, monitors compliance with the current Good Manufacturing Practices and Company policies, procedures and specifications. The QA Patient Safety Intern will assist in processing and investigating product defect customer complaints at Tolmar Inc.

Training & Development:
Gain real‑world experience in Quality Systems & Compliance (Quality Assurance), including regulatory compliance, complaint handling, data analysis, and cross‑functional collaboration.

Career Progression:
Enhance critical thinking, attention to detail, and regulatory knowledge, with mentorship from experienced professionals, providing insights into career paths in the pharmaceutical and/or medical device industries.

• Carry out responsibilities in accordance with the organization's policies, procedures, and state, Federal and local laws.
• Responsible for completing all training requirements.
• Ensuring compliance with company policy and Tolmar's Quality System.
• Assisting in processing, investigation, and trending of product defect complaints.
• Supporting documentation and resolution of customer reports and complaints.
• Working closely with and supporting the QA Patient Safety team by documenting, investigating, and/or processing customer complaints regarding product quality as assigned.
• Tracking investigation progress and contributing to system optimization.
• Supporting corrective and preventive actions related to product complaints.
• Collaborating with team members to enhance processes and assist with other QA Patient Safety related projects.
• Identify gaps and areas that need improvement and communicate and/or implement recommendations/changes.
• Accurately document detailed product information, complaint descriptions, and details in compliance with Good Documentation Practices (GDP).
• Handle product complaints efficiently in accordance with internal procedures. This includes registering complaints and gathering relevant data.
• Complaint Sample Handling:
  • Coordinate the return (shipping and handling) of complaint samples ensuring documentation reflects the tracking details Overseeing visual inspection of returned complaint samples and maintaining logs
  • Perform daily tracking and receipt of customer complaint samples for Tolmar
  • Evaluate returned samples and report initial evaluation findings to key personnel.
  • Perform destruction of customer complaint samples per internal procedures as instructed.
• Regulatory Compliance:
  Ensuring complaints are processed within established timelines to meet regulatory requirements and per internal procedures.
• Perform additional related duties as assigned.

The QA Patient Safety Intern is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well‑being of our patients and treat our employees and those we serve…