2024 Summer Intern - Gxp Quality Assurance Internship

Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis' platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. Join us and experience our unique culture while you develop and expand your career.
GxP Quality Assurance Internship
Summary:
The Summer Intern position will support the GxP Quality Assurance / Compliance (QA/C) organization at Ionis Pharmaceuticals, reporting to the Associate Director, QA/C. The candidate will own and lead projects to build an audit and inspection dashboard (see Projects/Responsibilities for details) to enhance real-time monitoring and data visualization that support Ionis' clinical and commercial products. This candidate will review GxP Regulatory Inspection history, collect trends and patterns, organize QA SharePoint, and work towards simplification of GxP QA processes. In this role, they will partner with internal and external stakeholders and will independently lead the project with provided guidance from mentors.
Program Highlights:

• The program is designed to complement a student's undergraduate and/or graduate studies with relevant, hands-on industry experience
• Ionis offers paid positions
• Weekly stipend
• Professional Networking
• Fun Group Outings
• End-of-program project presentations
• Housing/Travel assistance available for eligible, out-of-area interns
• Networking and bonding social events
• Interaction with diverse and motivated teams/departments

Responsibilities:
Audit and Inspection Dashboard

• Collaborate with the internal GCP/GLP/GVP/GMP QA team to understand the requirements and objectives for the dashboard.
• Design and develop a comprehensive GCP/GLP/GVP/GMP audit and inspection dashboard to visualize audit and inspection data, trends, and key performance indicators (KPIs).
• Integrate data from multiple sources and ensure data accuracy and consistency within the dashboard.
• Provide support and training to end-users on the functionality and features of the dashboard.

Inspection History

• Review scribe notes and compile regulatory inspection questions from previous GCP/GLP/GVP/GMP inspections conducted by relevant regulatory bodies.
• Review and categorize inspection questions based on regulatory topics, areas of concern, and inspection types.
• Analyze trends and patterns in past inspection questions to identify recurring themes or areas requiring special attention.
• Create a centralized repository or database of collected inspection questions and findings for easy reference and access.

Organize QA SharePoint

• Redesign and organize GCP/GLP/GVP Quality Assurance SharePoint sites to simplify document storage and retrieval.
• Create a guidance to maintain the SharePoint platform, permissions, and configurations.

QA Digital Guide

• Evaluate the global GxP QA team's existing workflow, process, and technology.
• Identify pain points, inefficiencies, and areas that need improvement. Research and select digital tools and technologies that can be applied to the areas of improvement.
• Create guidance on the tools that can be used by the team, along with examples, and provide training as applicable.

Requirements:

• Have strong and highly effective interpersonal, written, and communication skills.
• Have a methodical, organized, and creative mindset.
• Be comfortable working independently in a fast-paced environment.
• Have the ability to change priorities, have innovative thinking, and be flexible.
• Have a good understanding of Microsoft tools and strong computer skills.
• MUST be currently enrolled in a U.S. Undergraduate and/or Graduate Degree Program and not graduating prior to the completion of the Ionis internship
• MUST be able to begin internship between 6/11 and 6/17/2023
• MUST be able and willing to remain in program through at least 8/16/2023
• MUST be able and willing to commit to a minimum 40-hour work week
• Add information if your project will be either remote or onsite

Benefits:

• Gain experience and learn about the requirements of quality culture within a biotech company, including the Ionis Ways of Working and culture.
• Learn about FDA, EMA, ICH, and other regulations as applied to a clinical and commercial pharmaceutical/biotech company.
• Gain entrepreneurial and self-driven skills to enhance interpersonal, written, and communication skills.
• Will learn project management skills that are transferrable to different industries and business areas.
• Opportunity to enhance innovation and resolution and change agility.

Please visit our website, http://www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS00####
The pay scale for this position is $18 to $23 per hour.
NO PHONE CALLS PLEASE. PRINCIPALS ONLY. APPLICATION DEADLINE IS April 22, 2024. PLEASE INCLUDE A COVER LETTER RELEVANT TO THE POSITION APPLYING FOR. THE EVALUATION PROCESS MAY COMMENCE PRIOR TO THIS DEADLINE.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.