Harrow, Inc.

2nd Shift QA Manufacturing Specialist

United States · Full-time

Sponsorship not specifiedDetected 15 days ago

ExpressExcelGMPFDA RegulatoryCommunicationCritical ThinkingMicrosoft Office

About the role

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.

Participate in regulatory audits if required.
Responsible for generating deviations and change controls when 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.
Ability to complete tasks with little direction or need for supervisory follow-up.
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.

An expanding Retina Portfolio including IHEEZO ®, TRIESENCE ®, BYOOVIZ TM, and OPUVIZ TM
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
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.

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.
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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?
Performs duties following established company procedures and policies; performs other duties as assigned.

This listing is sourced directly from Harrow, Inc.'s careers page and normalized into a canonical job model.