QA Complaints Specialist

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 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 – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need.  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!

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

• An expanding Retina Portfolio including IHEEZO®, TRIESENCE®, BYOOVIZTM, and OPUVIZTM
• A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and FRESHKOTE®
• A peri-operative Surgical product line, led by TRIESENCE®, and BYQLOVITM
• A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO®, NATACYN®, and VERKAZIA®
• A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

Job Summary

The Quality Assurance Complaints Specialist ensures manufacturing procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. The position supports operational needs and activities in order to successfully achieve quality goals and complaints metrics.

Core Responsibilities

• Handles product complaints received from customer service department.

• Initiates, process and send notifications as required by applicable Standard Operating Procedures (SOPs).

• Interacts with customer service and customers to acquire additional information that may be required to effectively investigate a product complaint.

• Evaluate complaints for regulatory reportability and create and submit reports that comply with applicable regulations.

• Writes, investigates and ensures timely submission of complaints investigation.

• Reviews and approves complaint investigation submitted by other team members.

• 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 folders.

• Perform other duties and assume responsibilities as appropriate or assigned.

Qualifications & Requirements

• Bachelor’s degree required, preferably life sciences
• 2+ years of experience in pharmacy operation or experience in cGMP environment
• Must be able to facilitate collaboration, while knowing when to move to end analysis and recommend decisions
• Strong written, verbal and presentation communication skills
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) required
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards

Position Type

• On-Site

Travel

• None