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Harrow · 1 month ago

Quality Assurance Specialist II, CMO

United States

Full-time

Remote

Mid, Senior Level

5+ years exp

Harrow Health is a leading North American ophthalmic-focused pharmaceutical company committed to innovation and patient access to affordable medicines. The QA Specialist II will oversee and support external manufacturing operations, ensuring compliance with regulatory standards and providing guidance to junior team members.

BiotechnologyHealth CareMedical

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

Qualification

Quality AssuranceRegulatory ComplianceInvestigationsMicrosoft OfficeProblem SolvingCommunication SkillsOrganizational SkillsDecision MakingDetail-oriented