Quality Assurance Compliance Intern, CMO

<div class="content-intro"><p><em>Before reading the job post, we encourage you to watch this <a href="https://player.vimeo.com/video/746673398?h=813f818de3" target="_blank">video</a> about our company. </em><em>It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.</em></p> <p>&nbsp;</p> <p><strong>Who is Harrow?</strong></p> <p>Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world –&nbsp;<em>providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need</em>.&nbsp; We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of!</p> <p>Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:</p> <ul> <li><strong>An expanding</strong> <strong>Retina Portfolio</strong> including IHEEZO^®, TRIESENCE^®, BYOOVIZ^TM, and OPUVIZ^TM</li> <li><strong>A</strong> <strong>broad Dry Eye Disease product line</strong>, led by VEVYE^® and bolstered by well-known adjacent ocular surface disease products such as FLAREX^® and FRESHKOTE^®</li> <li><strong>A peri-operative Surgical product line</strong>, led by TRIESENCE^®, and BYQLOVI^TM</li> <li><strong>A Rare and Specialty product line</strong>, which includes various high-need and utility products such as ILEVRO^®, NATACYN^®, and VERKAZIA^®</li> <li><strong>A robust internal development pipeline</strong> with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01</li> </ul></div><p><strong>Job Summary</strong></p> <p>The <strong>QA Compliance Intern</strong> will provide foundational administrative and operational support to the Quality Department. This role is designed to offer a student or recent graduate hands-on experience in oversight of external manufacturing operations and Contract Manufacturing Organization (CMO) partnerships. As an intern, you will assist in ensuring compliance with international regulatory requirements and industry standards and support the internal quality team with various tasks and projects.</p> <p><strong>Core Responsibilities</strong></p> <ul> <li>Assist in the initiation and administrative tracking of incoming inquiries, including Product Quality Complaints (PQCs), Adverse Events (AEs), and Medical Inquiries (MIs).</li> <li>Support the Quality Team in maintaining seamless communication between internal departments (Supply Chain, Pharmacovigilance, Regulatory Affairs) and external manufacturing partners.</li> <li>Learn to support the initiation of investigations, CAPAs (Corrective and Preventive Actions), change controls, and validation documentation within a Good Manufacturing Practice (GMP) environment.</li> <li>&nbsp;Monitor the general QA mailbox, ensuring inquiries are routed to the appropriate stakeholders in a timely manner.</li> <li>Assist in the maintenance and implementation of internal policies, procedures, and training programs.</li> <li>Contribute to the organization of files and documentation required for internal and external audits.</li> <li>&nbsp;Provide general project management support for the Quality Department, including data entry into Excel and drafting correspondence.</li> </ul> <p><strong>Qualifications &amp; Requirements</strong></p> <ul> <li>Currently enrolled in or a recent graduate of a BA/BS program in Life Sciences, Chemistry, Pharmacy, or a related field.</li> <li>Previous internship or coursework related to Quality Assurance, Quality Control, or Regulatory Compliance is a plus but not required.</li> <li>Excellent verbal and written communication skills with a focus on professional email etiquette.</li> <li>Proficiency in Microsoft Office Suite (Word, Excel, Outlook) is required.</li> <li>High attention to detail and the ability to manage multiple assignments simultaneously while meeting deadlines.</li> <li>Ability to ask compelling questions and a desire to understand</li> <li>Ability to work both autonomously and collaboratively in a fast-paced environment.</li> <li>Basic knowledge of CAPAs, Deviation investigations, Change Controls, and Supplier Qualification Program.</li> </ul> <p><strong>Position Type&nbsp;</strong></p> <ul> <li><em>Remote</em></li> </ul> <p><strong>Travel</strong></p> <ul> <li><em>(5% travel)</em></li> </ul>

Qualifications

• Department: QA