Job Summary

The QA Specialist I is responsible for administratively overseeing and supporting external manufacturing operations with our global CMO (Contract Manufacturing Organization) partners. As an individual contributor, this role provides QA oversight of CMO operations in compliance with business agreements, international regulatory requirements, and industry standards. Additionally, the position involves providing administrative support to the internal quality department, including managing tasks and projects for both department management and team members.

Core Responsibilities

• Act as QA Initiator and Investigator for Product Quality Complaints, ensuring timely initiation and investigation in accordance with compliance requirements.

• Act as the key point of contact for internal teams and external manufacturing partners, fostering cross-functional collaboration while managing inquiries within the general QA mailbox.

• Support the development and execution of CAPAs, change controls, validation documentation, and other GMP-related activities.

• Deliver exceptional customer service related to Harrow Eye products, ensuring a commitment to achieving 100% customer satisfaction.

• Collaborate closely with Harrow Eye’s External Manufacturing Team, Supply Chain, Pharmacovigilance, and Regulatory Affairs to maintain seamless communication with external manufacturing partners and internal stakeholders.

• Effectively communicate issues, risks, and proposed solutions across the organization.

• Assist in implementing policies, procedures, and training programs while providing support to the Quality Team on various tasks and initiatives.

• Contribute to the preparation and execution of internal and external audits, as required.

• Perform additional duties and responsibilities as assigned

Qualifications & Requirements

• Associate's degree or equivalent work and education in a related field; BA preferred.

• 2+ years of experience in the pharmaceutical or related industry. Experience in quality assurance, quality control, or compliance is preferred but not required.

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

• Basic knowledge of relevant regulations and guidance documents

• Basic knowledge of CAPAs, Deviation investigations, Change Controls and Supplier Qualification Program.

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

• Excellent oral 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, Excel, and PowerPoint required.

• Knowledge of GxP systems is preferred but not required.

• Exposure to AI tools such as ChatGPT, Claude, etc.