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.

Purpose and Scope

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.

Essential Duties & Responsibilities

• 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.

Core Values

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 as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise-wide mindset that lifts the whole organization.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Knowledge, Skills & Abilities

• Ability to adapt to change and demonstrate flexibility.
• Excellent interpersonal, written, and verbal communication skills.
• Good understanding of the operational environment and analytical skills.
• Self-motivation and teamwork skills.
• Proficiency in Microsoft Office Applications.
• Familiarity with Quality Systems and complaint handling is preferred.
• Experience with SOP writing is preferred.
• Basic knowledge of Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA), and other regulatory compliance regulations and standards preferred.
• Fast learner of technical and process skills/knowledge.
• Superior attention to detail, quality, accuracy and timelines.
• Strong time management and prioritization skills; ability to multi-task.

Education & Experience

• Currently pursuing a Bachelor's degree in Science, Engineering or related field from an accredited college or university.
• Demonstrated experience with Microsoft Office Suite applications.
• Previous internship or coursework related to Quality, Regulatory, or Medical Devices is preferred.
• Training or familiarity with complaint-handling and problem-solving methodologies is preferred.

Working Conditions

• Working conditions are typical for an office environment in addition to a laboratory setting to include exposure to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput environment.
• Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects and/or small parts including inspection of complaint samples, using assembly at a distance close to the eyes.

Compensation and Benefits

• Base rate is $19.00 per hour
• Benefits include medical insurance and 401k participation
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  Benefits summary: https://www.tolmar.com/careers/employee-benefits

  
  

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidate's qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.