Quality Assurance Specialist I, CMO

Harrow, Inc.

3d

About The Position

The QA Specialist I administratively oversees and supports external manufacturing operations with Harrow’s global contract manufacturing organization (CMO) partners. As an individual contributor, the role provides quality assurance oversight of CMO operations in compliance with business agreements, international regulatory requirements, and industry standards. The position also provides administrative support to the internal quality department by managing tasks and projects for department management and team members.

Requirements

• Associate's degree or equivalent work and education in a related field.
• At least 2 years of experience in the pharmaceutical or a related industry.
• Strong organizational skills and the ability to follow assignments through to completion.
• Basic knowledge of relevant regulations and guidance documents.
• Basic knowledge of CAPAs, deviation investigations, change controls, and supplier qualification programs.
• Strong decision-making capability, ability to ask compelling questions, think strategically, and understand the global impact of decisions.
• Excellent oral and written communication skills.
• Detail-oriented, with problem-solving and decision-making abilities.
• Experience working autonomously and a proven ability to meet deadlines.
• Proficiency with Microsoft Office software, including Outlook, Word, Excel, and PowerPoint.
• Exposure to AI tools such as ChatGPT or Claude.

Nice To Haves

• Bachelor of Arts degree.
• Experience in quality assurance, quality control, or compliance.
• Knowledge of GxP systems.

Responsibilities

• Act as QA Initiator and Investigator for Product Quality Complaints, ensuring timely initiation and investigation in accordance with compliance requirements.
• Serve as a key contact for internal teams and external manufacturing partners, foster cross-functional collaboration, and manage inquiries in the general QA mailbox.
• Support the development and execution of CAPAs, change controls, validation documentation, and other GMP-related activities.
• Provide customer service related to Harrow Eye products, with a commitment to customer satisfaction.
• Collaborate with the External Manufacturing Team, Supply Chain, Pharmacovigilance, and Regulatory Affairs to maintain communication with external manufacturing partners and internal stakeholders.
• Communicate issues, risks, and proposed solutions across the organization.
• Assist with implementing policies, procedures, and training programs, and support the Quality Team on tasks and initiatives.
• Contribute to the preparation and execution of internal and external audits as required.
• Perform additional duties and responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree