Production Sterilization 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 one of the leading U.S. ophthalmic-focused pharmaceuticals companies.  Aside from being a for-profit company, from a cultural perspective, all members of the Harrow Family are proud of our commitment to (1) innovation, (2) patient access to, and affordability of, our medicines, and (3) that we have never turned down an ophthalmologist doing mission work around the world – to provide free-medicines – to support their work to give to the gift of sight to those most in need.    

Harrow owns numerous branded pharmaceutical products, including Iopidine, Maxitrol, Moxeza, Triecense, Vigamox, Maxidex, Nevanac, Ilevro, and Iheezo. In addition, Harrow owns and operates ImprimisRx, the nation’s leading ophthalmology-focused compounded pharmaceuticals, including its FDA-registered and FDA-inspected 503B outsourcing facility and a 50-state mail order pharmacy – both of which are in Ledgewood, New Jersey.

Harrow also holds non-controlling equity positions in Eton Pharmaceuticals, Surface Ophthalmics, and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries, and owns royalty rights in four clinical-stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals. 

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

Job Summary

The Production Sterilization Specialist will be responsible for conducting labeling, packaging, and production support activities to support commercial manufacturing. Under the direction of the Production Supervisor/Team Leader, the Production Support Associate will work hands-on under ISO7, ISO8, and other classified areas with various manufacturing production equipment and technologies. Daily responsibilities vary, including operating cleaning machines and preparing supplies for manufacturing by cleaning and disinfecting. 

Position Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.
• Reports any accidents, incidents, injuries, or illnesses immediately and notifies the manager of any workplace hazards, unsafe acts, or conditions.
• Accurate completion of product documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements.
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.
• Excellent organization and time-management skills are required. Must promptly manage a heavy workload and aggressive timelines, prioritize, and work under pressure.
• Cleaning, sanitizing, and disinfection of equipment and components required for production. 
• Works with Warehouse Department to ensure all components are available ahead of time for production. 
• Completes all necessary cleaning and sanitizing of production equipment and area.
• Stages material for production use.
• Operation of cleaning equipment including but not limited to Autoclave, Fedegari, and Depyrogentation oven.
• Performs calibration of check weighing.

Qualifications

• High School Diploma or equivalent work and education in a related field are required.
• 1-3 years of experience working in the pharmaceutical industry and within aseptic clean room environments.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Ability to handle sensitive information with a high degree of confidentiality.
• Ability to work in a fast-p