companyOcular Therapeutix, Inc. logo

Quality Control Analyst - Data Review

On-site Full-time $80K/yr - $90K/yr

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Key ResponsibilitiesQuality Control Data ReviewConduct thorough reviews of analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance testing). Verify calculations, instrument suitability, standards, sequences, and chromatographic integration. Ensure compliance with compendial methods, validated procedures, and specifications. Review microbiology data (bioburden, endotoxin, sterility, ID, EM, growth promotion, device-specific assays). Analyze EM trending data and document deviations and sterility assurance. Confirm accuracy in incubation records, media traceability, sample handling, and method compliance. Review logbooks, equipment records, and supporting documentation for completeness. Ensure data integrity through audit trails and ALCOA+ compliance. Validate documentation in LIMS, notebooks, and electronic systems. Documentation & ComplianceEnsure that reviewed data meets cGMP and FDA/EMA regulatory standards.

About the job

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a pioneering biopharmaceutical company dedicated to the formulation, development, and commercialization of groundbreaking therapies for eye diseases and conditions, utilizing our innovative bioresorbable hydrogel-based formulation technology, ELUTYX™. With a robust pipeline of drug delivery solutions, we aim to simplify and enhance the current standard of care, positioning ourselves as a leader in the ophthalmic industry.

At our Bedford, MA headquarters, we foster a vibrant culture that encourages employees to grow and achieve their career aspirations. We promote innovative thinking, cross-functional collaboration, and creativity.

Position Summary

The Quality Control Analyst, Data Review, plays a crucial role in ensuring the integrity of analytical chemistry and microbiology data for small-molecule and combination products. This position is essential for maintaining accurate and compliant electronic and paper QC records according to cGMP, GLP, and ALCOA+ data integrity standards, supporting batch release, stability programs, environmental monitoring, method validation, device testing, and regulatory submissions.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is at the forefront of biopharmaceutical innovation, focusing on the development of advanced therapies for ocular conditions. Our commitment to excellence and our unique technological approach set us apart in the ophthalmic market.

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