Quality Assurance Specialist 503B chez Harrow, Inc.
Harrow, Inc. · Ledgewood, États-Unis d'Amérique · Onsite
- Professional
- Bureau à Ledgewood
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 Associate is responsible for ensuring that the regulatory and quality standards are met during the manufacturing and packaging process. This position is accountable for driving high quality standards and compliance with regulatory and cGMP requirements. The Quality Assurance Specialist will meet the company goals for product quality and production efficiency. This position will ensure that the operations are following the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. The QA Specialist will participate in audits and inspections and will be responsible for writing and/or managing all deviations, CAPAs, product complaints, and change controls at the site.
Position Responsibilities
- Participates in regulatory audits, assists in the maintenance of audit records, and documenting follow-up from audits.
- Responsible for writing and/or managing investigations/deviations.
- Performs or assists process owners with the root cause analysis.
- Responsible for generating and monitoring CAPAs and change controls for the site.
- Responsible for conducting impact assessments and risk assessments.
- Prepares and monitors Quality Metrics and KPIs.
- Performs duties in accordance with established company procedures and policies; performs other duties as assigned.
Requirements
- Bachelor’s Degree or a combination of education and experience in Science, Microbiology, or Engineering or related life sciences.
- 3+ years of experience in cGMP quality operations and FDA regulations or a 503B outsourcing facility, aseptic/parenteral manufacturing/ development environment, or equivalent technical experience.
- 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.
Work Environment/Physical Demands
- 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.
Position Type and Expected Hours of Work
- This is a full-time position in a compounding pharmacy with regular operations occurring between M-F in our Ledgewood, NJ location.
- Working hours 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 holidays and work during inclement weather may be required.
