Senior Associate, Quality Assurance

Overview

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its ELUTYX™ hydrogel-based formulation technology. The Senior Associate, QA will provide Quality Assurance oversight for the production of Drug Products, supporting end-to-end operations from technology transfer and clinical production through commercialization, and will oversee Quality Control activities to ensure compliance with applicable regulatory requirements and internal quality standards.

This role includes quality oversight and phase-appropriate cGMP guidance throughout the product lifecycle.

• Provide QA support for site operations, including in-house manufacturing and activities performed at contract development and manufacturing organizations (CDMOs), as well as the distribution of Ocular products through the supply chain workflow.
• Provide on-floor QA support during critical manufacturing processes.
• Release manufacturing suites and manage batch/product changeovers to enable continued manufacturing.
• Participate in cross-functional teams to resolve Quality-related issues impacting operations.
• Review and approve documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations, and CAPAs.
• Participate in Change Control Review Board and provide Quality input and assessment.
• Perform quality-related activities within Quality Systems including Change Control, Deviation Reporting, and CAPA.
• Author, review, and approve internal quality documents (SOPs, investigations, etc.).
• Support QA leadership in maintaining QA Operations readiness and compliance.
• Support Annual Product Review (APR) reporting and data analysis to ensure process control.
• Review and approve QC documentation, including test records, analytical data, and logbooks.
• Ensure adherence to SOPs, test methods, and regulatory requirements (FDA, EMA, ICH).
• Review and approve Certificates of Analysis (CoA), analytical test results, reports, and stability data.
• Perform other quality assurance duties as assigned.

• Bachelor’s degree in a relevant scientific discipline.
• 5+ years of experience in pharmaceutical, biotech, or medical device industries.
• Strong knowledge of GMP, GLP, and regulatory expectations.
• Understanding of analytical testing and laboratory workflows.
• Familiarity with out-of-specification (OOS) investigations, deviations, and CAPA processes.
• Excellent organizational skills and attention to detail.
• Good verbal and written communication skills.
• Strong interpersonal skills and ability to work effectively in a team.
• Computer literacy with proficiency in MS Office (Excel, PowerPoint, etc.).
• Ability to make decisions and resolve issues with minimal guidance.

• Office environment (primary).
• Clean room/manufacturing environment when on-floor QA support is required.

Salary Range: $109,000 - $121,000 USD

Ocular Therapeutix is an Equal Opportunity Employer and complies with applicable federal, state, and local laws regarding nondiscrimination. For information on how candidate information is collected, stored, and utilized please see our privacy policy at ;
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