Quality Control Data Reviewer

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 get to know us.

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. 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:

• A
  broad Dry Eye Disease product line
  , led by VEVYE ® and bolstered by well-known adjacent ocular surface disease products such as FLAREX ® and FRESHKOTE ®
• A peri-operative Surgical product line
  , led by TRIESENCE ® , and BYQLOVI TM
• A Rare and Specialty product line
  , which includes various high-need and utility products such as ILEVRO ® , NATACYN ® , and VERKAZIA ®
• A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

The Quality Control Data Reviewer supports Quality Control laboratory operations by making sure analytical data and reports are accurate, complete, traceable, and compliant before results are released. The role verifies that testing was performed according to validated methods, approved specifications, protocols, SOPs, and cGMP requirements. It also verifies that data meets ALCOA+ data integrity principles. The Data Reviewer performs second-person review of chromatographic and other analytical data across paper and electronic systems.

They identify discrepancies, errors, and compliance risks and elevate them, and they serve as the laboratory’s subject matter expert on data review practices.

• Review Quality Control data and analytical reports, including release testing, stability testing, and analytical method validation, for compliance with approved specifications, written procedures, GMP requirements, and applicable compendial monographs in a timely manner.
• Review chromatographic data, laboratory notebooks, associated documentation, and sample results for scientific soundness, accuracy, completeness, traceability, appropriate data interpretation, and accurate representation of the final reported results.
• Review equipment and instrument logbooks to ensure entries are accurate, complete, contemporaneous, and compliant with applicable procedures.
• Verify appropriate audit trail records as part of the data review process and assess electronic data for completeness, traceability, and compliance with applicable data integrity requirements consistent with 21 CFR Part 11
• Document and communicate data review findings, including deficiencies, discrepancies, or observations identified within…