Quality Assurance Inspector 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

The Quality Assurance Inspector will meet the company goals for product quality and production efficiency. This position will help ensure that Operations is following the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. The QA Inspector will participate in audits and inspections and will be responsible for visual inspection of injectable products, secondary inspection of all products, raw material release and management, quality on the floor and for investigation, writing and managing deviations related to visual inspection.

Core Responsibilities

• Perform QA visual Inspection of injectable drug products
• Performs QA secondary inspection of all products.
• Releases or rejects raw materials and components.

• Sampling, inspection, and status tagging of incoming raw material and components.
• Product Label, Insert and printed material review and approval.
• Annual and Semi Annual data trending and reporting on visual inspection.
• Maintains visual inspection defect library for Quality and Production use.
• Assist in Quality on the floor.
• Participate in regulatory audits, assists in maintenance of audit records and documenting follow up from audits.
• Performs or assists process owners with root cause analysis.
• Responsible for generating and monitoring CAPAs and Change Controls for related areas of responsibility.
• Prepares and monitors Quality Metrics and KPI’s.
• Perform duties in accordance with established company procedures and policies.
• Perform other duties as assigned.

Qualifications & Requirements

• 1-3 years of progressive experience within cGMP quality operations and FDA regulations or a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment or equivalent technical experience.
• BS in Scientific field preferred
• Recent experience with aseptic drug product manufacturing
• A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices and Good Documentation Practices.
• Familiarity with FDA inspections and audits
• Investigation writing skills
• 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 other must be able to learn additional software as required).
• Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.

Position Type 

• On-Site
• This is a full-time position in a compounding pharmacy with regular operations occurring between M-F in our Ledgewood, NJ location. Working hours are 8 hours per day and may vary anywhere from several hours before opening to several hours after closing. Additionally, weekend hours may be needed depending upon workload demands. Rotating shifts as well as holiday and work during inclement weather may be required.

Travel

• None

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.

• 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 
• The employee must have 20/20 vision with correction with color perception.
• The employee may frequently be required to sit and talk or hear.
• The employee is required to stand or sit
• The employee must occasionally lift and/or move up to 25 pounds

AAP/EEO Statement

ImprimisRx believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing, and retaining the best talent for our business, challenging our people, demonstrating a "can-do" attitude, and fostering a collaborative and mutually supportive environment.

Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation. 

ImprimisRx is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.