Join Our Team as a Quality Assurance Specialist II!
At Harrow, a prominent North American ophthalmic-focused pharmaceutical company, we pride ourselves on fostering an entrepreneurial culture where every member of our Harrow Family is empowered to take charge of their role. Our commitment to innovation, patient access to affordable medicines, and our philanthropic efforts to support ophthalmologists in mission work create an inspiring environment for all team members. If you share our passion for making a difference, we encourage you to explore how you can contribute to our exceptional company.
We offer a comprehensive ophthalmic pharmaceutical portfolio that includes:
• An expanding Posterior Portfolio, featuring IHEEZO and TRIESENCE.
• A range of Dry Eye Disease products, highlighted by VEVYE and complemented by trusted ocular surface disease products like FLAREX and TOBRADEX ST.
• A Specialty Anterior Segment product line with critical offerings such as ILEVRO, NEVANAC, and VERKAZIA.
Job Summary:
The Quality Assurance Specialist II will play a key role in overseeing and supporting our global CMO partners in manufacturing operations. This individual contributor position is integral in providing mid-level QA oversight in line with our business agreements and international regulatory standards. In addition, this role includes administrative support and guidance for junior team members within our quality department.
Core Responsibilities:
• Collaborate closely with the External Manufacturing, Supply Chain, and Regulatory Affairs teams to ensure clear communication with our external manufacturing partners.
• Serve as a single point of contact for QA technical support for both internal teams and external partners.
• Effectively communicate issues, risks, and proposed solutions within the organization.
• Assist with and provide QA approval for investigations, CAPAs, changes, validation documentation, and other GMP-related documents.
• Offer support and guidance to manufacturing partners and the QA CMO team.
• Facilitate the implementation of policies and procedures to ensure CMO compliance, including the development of quality agreements.
• Conduct batch record reviews and lot disposition activities as necessary.
• Support internal and external audits as required.
• Create and revise standard operating procedures as necessary.
• Coach and mentor junior team members in a peer-to-peer environment.
• Other duties as assigned.
Qualifications & Requirements:
• A minimum of a BS/BA in a scientific discipline.
• 5+ years of related experience, with at least 3 years in quality assurance, quality control, and compliance.
• Proven track record in investigations, deviations, change controls, product quality complaints, and supplier qualification.
• Strong organizational skills with the ability to see assignments through to completion.
• Knowledge of relevant regulations and guidance documents.
• Excellent decision-making capabilities, with strong questioning and strategic thinking skills.
• Outstanding verbal and written communication skills.
• Detail-oriented with solid problem-solving and decision-making abilities.
• Experience working autonomously and meeting deadlines.
• Proficiency in Microsoft Office applications, including Outlook, Word, and Excel.
