Quality Control Sample/Stability Coordinator 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 assist with the QC samples, including raw materials, stability, in-process, and finished drug products. This position has to do Daily temperature and RH monitoring of stability chambers, study requests for selected studies, initiate/load stability samples in the stability chamber, create study files in the software, pull samples from the stability chamber as per the pull schedule. Raw materials, stability and finished drug products sample send out for testing at laboratories with appropriate documentation (In-house, and approved contract labs) and follow-up for results. Maintain sample storage space (keep arranging samples upon pull to make more room for upcoming new studies), maintain stability sample inventory by updating iStability software, enter result in the iStability software and transcribe data in FP, RM spec upon receipt of CoA’s from testing laboratories, generate stability summary reports, perform regression analysis report as needed, and create/revise Stability Protocols, Stability specifications and Finished Product specifications as needed. Also, update the tracking file to keep up to date information for the testing status of each sample sent out for testing

Position Responsibilities

• Handles all QC samples, including raw materials, finished drug products, and stability samples, for submission to appropriate analytical testing laboratories, including making out submission paperwork or entry forms and shipping the samples to outside laboratories
• Enters all raw material and finished drug product sample information into the sample management software
• Enters anticipated dates for QC release of testing data into disposition tracking software
• Enters all stability sample information into the stability management software
• Pulls raw material, finished drug product, and stability testing data from data repositories
• Follows up with laboratories on past due test results
• Enters raw material and finished drug product test results into the sample management software
• Prepares executed test specifications for raw material and finished drug product testing
• Prepares stability protocols
• Enters stability test results into the stability management software
• Creates stability reports
• Provides stability data and analysis for Annual Product Quality Review (APQR) reports.
• Orders, receives, logs, disposes of, and maintains inventory of reagents, samples, standards, supplies, etc., as per applicable procedures and make them available for in-house laboratory usage
• Other duties will be assigned as required to support QC and Quality

Requirements

• Bachelor’s Degree in scientific discipline preferred.
• 0- 5 years of pharmaceutical laboratory environment experience; or equivalent combination of education and experience.
• Must be computer literate, with experience in spreadsheet and database applications
• Must be detail oriented
• Must be well organized
• Must have the ability to work on multiple different tasks within a workday
• Must have a positive teamwork attitude
• Excellent interpersonal, oral, and written communication skills
• Maintains confidentiality of sensitive information
• Ability to meet attendance standards.  All full-time employees are required to minimally work a 40-hr week.  Sometimes it may be necessary to work additional hours to accomplish the required tasks to meet deadlin. 

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.