Quality Assurance Complaints Specialist 503B

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 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 High School Graduate will be considered but preferably with Bachelor's Degree or a combination of education and experience in related 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 N/A Work Environment & Physical Demands While performing the responsibilities of the job, the work environment characteristics are representative of the environment the job holder will encounter, and the physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions. The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, and crouch. The employee must occasionally lift and/or move up to 25 pounds. A cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves, and steel-toe boots be worn. Also, no makeup or jewelry can be worn when working in a clean room environment. Specific vision abilities in this job include close vision, depth perception, and the ability to adjust focus.