Job Summary

The QA Specialist II is responsible for overseeing and supporting external manufacturing operations of our global CMO Partners. The QA Specialist II position is an individual contributor role responsible for providing mid-level QA oversight of CMO operations in accordance with business agreements and international regulatory and industry standards. Secondarily, this role provides mid-level administrative support and basic general peer-to-peer guidance to junior team members to the internal quality department. Duties also include administrative tasks and projects for both the management and for members of the quality department.

Core Responsibilities

• Partner closely with Harrow Eye’s External Manufacturing, Supply Chain and Regulatory Affairs team to ensure consistent and collaborative communication to external manufacturing partners

• Work cross functionally to provide a single point of contact for QA technical support to internal team and external manufacturing partners

• Effectively communicate issues, risks, and proposed solutions within the organization

• Assist with, conduct and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation.

• Provide communication, support, and guidance to manufacturing partners and within the QA CMO team

• Facilitates implementation of policies and procedures for CMO compliance, including development of quality agreements. Quality business processes and product disposition in accordance with team derived strategy and business realities.

• Perform batch record review and lot disposition activities as required

• Support internal and external audits as needed

• Create and revise standard operating procedures as needed

• Coach and mentor junior team members on a peer-to-peer level basis.

• Other duties as assigned.

Qualifications & Requirements

• A minimum of BS/BA in a scientific disciplinary.

• 5+ years related industry experience with a minimum of 3 years’ experience in quality assurance, quality control and compliance.

• Proven track record on investigations, deviations, change controls, product quality complaints and supplier qualification.

• Strong organizational skills, including ability to follow assignments through to completion.

• Knowledge of relevant regulations and guidance documents

• Strong decision-making capability and ability to ask compelling questions and to think strategically and understand global impact of decision

• Excellent verbal and written communication skills

• Detail-oriented with skills in problem solving and solid decision-making abilities

• Experience with working autonomously with proven ability to meet deadlines

• Proficient in the use of standard Microsoft Office software products, including Outlook, Word, and Excel required.