Quality Assurance Manufacturing 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 North American ophthalmic-focused pharmaceutical company. 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 Posterior Portfolio including IHEEZO^® and TRIESENCE^®
• 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
• A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO^®, NEVANAC^®, and VERKAZIA^®

Job 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. 

Core 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 documenting routine monitoring activities and working with applicable department for correction
• Performs duties following established company procedures and policies; performs other duties as assigned.

Qualifications & Requirements

• 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.

• High school degree
• BS in the Scientific field preferred

• 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. 

Position Type

• On-Site
• Full-time position in a manufacturing facility with regular operations between M-F in our Ledgewood, NJ location. Working hours may vary from several hours before opening to several hours after closing. Additionally, weekend hours may be needed depending upon workload demands. Along with possible rotating shifts and holiday work during inclement weather.

Travel

• Up to 5%

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 talk or listen.
• The employee is required to stand or sit.
• The employee must occasionally lift and/or move up to 25 pounds
• May work with hazardous materials and chemicals
• 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 the clean room environment
• Specific vision abilities by this job include close vision, depth perception and ability to adjust focus