Intern - QA Patient Safety

Tolmar Careers•Windsor, CO

11h•$19

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

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.
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.

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.