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.
Position Summary
This position will ensure that the operations follow the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. The QA Manufacturing Specialist will provide Quality oversight of the Manufacturing and Production areas, including compounding, filling, inspecting, and labeling/packaging. Management includes the periodic review of in-process activities such as cleaning, weighing, aseptic filling, material status verification, compounding, batch record documentation accuracy, logbook documentation accuracy, and room/line clearances.
Responsibilities:
- Provides Quality oversight of Production activities, including compounding, aseptic filling, inspection, and labeling/packaging on the floor.
- Provides Quality oversight of cleaning activities to ensure compliance with cleaning requirements.
- Product label review and approval.
- Oversight and confirmation compliance with Filling Operations, including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms, and batch records.
- Verification of proper gowning by all personnel in all areas of Production.
- Generation of deviations, issuance of CAPAs, and Change Controls in response to observations.
- Oversee all Quality aspects on the floor
- Participate in regulatory audits if required.
- Performs or assists process owners with the root cause analysis.
- Responsible for generating deviations and change controls when required.
- Performs duties following established company procedures and policies; performs other duties as assigned.
Qualifications
- Three-plus years of experience with aseptic drug product manufacturing is required.
- A fundamental, working knowledge of safety, quality systems, and quality assurance concepts are required, including the application of current Good Manufacturing Practices and Good Documentation Practices.
- Strong familiarity with manufacturing processes, operations, automation, and equipment/facilities.
- Ability to complete tasks with little direction or need for supervisory follow-up.
- Strong written, verbal, and presentation communication skills.
- Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and others must be able to learn additional software as required).
- Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
- Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
- Work schedule flexibility.
Experience:
- 3-5 years of progressive experience in cGMP quality operations and FDA regulations, a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment, or equivalent technical experience.
Education/Training
- High school degree
- BS in the Scientific field preferred
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.
