Quality Assurance Complaints Associate

Before reading the job post, we encourage you to watch this video about our company. 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.

 

Who is Harrow?

Harrow (Nasdaq: HROW) is a leading U.S. ophthalmic-focused pharmaceutical company. The Company was founded and continues operating based on the highest corporate values. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to and affordability of our medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need.

At Harrow, we foster our individual and collective entrepreneurial and creative spirits. We focus on pursuing opportunities for drug candidates in underserved markets. We are data-driven and use our access to real-world clinical experience to lower the investment risks of our work. We concentrate on the commercial appeal of high-value assets, and our objective is to seek to make paradigm-shifting medicines available to patients as soon as possible. Our approach to finding high-value opportunities and balancing risk with real-world experience can deliver exceptional value for all our stakeholders.

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

• IHEEZO:
•  A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and TOBRADEX® ST;
• TRIESENCE®:
•  A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO®, NEVANAC®, and VERKAZIA®;
• ImprimisRx is the nation’s leading ophthalmology-focused compound pharmacy, including an FDA-registered and FDA-inspected 503B outsourcing facility and a 50-state mail-order pharmacy. The division of Harrow serves as an innovation hub and plays a vital role in Harrow’s mission to help patients maintain their gift of sight.

Job Summary

The Quality Assurance Complaints Associate ensures customer complaints are received, categorized and logged in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and Food and Drug Administration (FDA) standards.  The position supports operational needs and activities to successfully achieve quality goals and complaints metrics.

 

Core Responsibilities

• Handles product complaints received from customer service department
• Initiates, processes and sends notifications as required by applicable Standard Operating Procedures (SOPs)
• Writes, investigates and ensures timely submission of minor complaint investigations
• Updates complaint data on a continuous basis
• Interacts with customer service and customers to acquire additional information that may be required to effectively investigate a product complaint
• Gathers requested information to successfully process all complaints
• Tracks and trends complaints to determine if elevation to upper management is required
• May be required to create complaint metrics from complaint data

 

• Collaborates with other departments to ensure technical issues are being addressed and investigations are conducted thoroughly
• Initiates applicable Corrective Action/Preventative Action (CAPA) plans.
• Accurately maintain product complaint logs (softcopy and hardcopy) through internal database tracking system

and complete all filing and closing procedures as required by applicable Standard Operating Procedures (SOPs)

• Responsible for ensuring that paperwork is complete for each complaint folder
• Perform other duties and assume responsibilities as appropriate or assigned

 

Qualifications & Requirements

• High School Graduate will be considered but preferably with Bachelor’s Degree or a combination of education and experience in related life sciences.
• 1+ years of experience in pharmacy operation, pharmaceutical industry or experience in cGMP environment
• Must be able to facilitate collaboration, while knowing when to move to end analysis and recommend dec