Intern - Quality Systems

About Tolmar

Are you interested in learning new skills, exploring pharmaceutical research and manufacturing, networking with experts, and building a resume that opens doors? Join us to jumpstart your career! At Tolmar, you will connect with like-minded professionals in a supportive community. This is a place where you can make a meaningful impact and feel empowered by the abundant opportunities for growth.

Tolmar, Inc. is a fully integrated pharmaceutical company based in Colorado. We develop, manufacture, and distribute both branded and generic prescription medications globally, focusing on oncology, urology, and pediatric endocrinology. Our long-acting injectables and oral medications offer innovative treatment options that meet the diverse needs of patients worldwide. By leveraging emerging technologies and developing new products, we aim to simplify treatment delivery and enhance the overall patient experience.

Quality Systems/Quality Management System

Quality Systems Management can be thought of as the process that makes sure our products are manufactured and distributed properly, and are consistent and bond by documentation, training and ownership. The goal is to achieve and maintain a desired level of quality within the organization and monitor and report and ensure we focus on the health of our systems and employees.

The Quality Systems team defines the requirements needed to ensure the processes and procedures are robust and act as the conduit to meet patient safety and regulatory compliance.

The core benefits of a QMS include:

• Elevated consistency and standardization of processes and outputs
• Reduced errors and increased operational efficiency
• Improved customer satisfaction through the delivery of quality products and services
• Continuous evaluation and improvement of organizational operations

Tolmar Quality Systems is responsible for ensuring oversight of governing quality processes and procedures align with pharmaceutical compliance and what is needed to meet our product and process regulations and validation as well as measuring and monitoring timelines and procedural requirements.

Proposed Work Description

The nature of business is flexibility and knowing priorities can shift according to the needs of the company/department. Therefore, the work described below is a sampling of the kinds of work we expect this position to entail:

• Assisting, tracking and maintaining quality system records coming due to help prevent users from missing due dates.
• Assist in process improvements, creating new dashboards, routing documents, verifying and routing Logbooks.
• Follow up with owners of paused, overdue and ageing documents.
• Assist, gather and prepare weekly and monthly Key Performance Indicators (KPIs)
• Prepare agendas and slides prior to department board meetings (Veeva Core, Change Control, etc.).
• Support various quality management system improvements (Learning, Documents, and Quality).
• Final review of executed Corrective and Preventive Actions (CAPA) and Effectiveness Checks (EFF).

Knowledge, Skills & Abilities

• Strong communication skills and ability to work collaboratively.
• Quality assurance and compliance interested in the pharmaceutical industry.
• Effective organization and attention to detail.
• Ability to interact collaboratively and effectively in a team environment.
• Well-developed oral and written communication skills
• Ability to work independently and efficiently.
• Ability to manage and prioritize multiple projects in a fast-paced environment.
• Strong time management skills.
• Proficient computer skills with demonstrated experience in working with Microsoft Suite (Word, Excel, PowerPoint, Project, and Outlook).

Core Values

The Intern is expected to work within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating 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.
• 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 collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & 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.

Education & Experience

• Actively perusing a college - or graduate-level degree in a scientific or engineering field.
• Quality assurance and compliance interest in the pharmaceutical industry.

Working Conditions

• Working conditions are normal for an office environment.
• Work will be on-site in Fort Collins.

Compensation and Benefits

• Base rate is $19.00 per hour
• Benefits include medical insurance and 401k participation
• 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