Ocular Therapeutix, Inc. · 8 hours ago
Quality Control Analyst, Data Review
Bedford, MA
Full-time
Onsite
Mid Level
$80K/yr - $90K/yr
3+ years expOcular Therapeutix, Inc. is a biopharmaceutical company focused on innovative therapies for eye diseases. The Quality Control Analyst, Data Review, is responsible for reviewing analytical chemistry and microbiology data to ensure compliance with regulatory standards and data integrity.
BiotechnologyHealth CareMedical Device
Responsibilities
Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance testing)
Verify calculations, instrument suitability, standards, sequences, and chromatographic integration
Ensure testing complies with compendial methods, validated procedures, and specifications
Review microbiology data (bioburden, endotoxin, sterility, ID, EM, growth promotion, device-specific assays)
Assess EM trending data, alert/action limit excursions, and sterility assurance documentation
Verify incubation records, media traceability, sample handling, and method compliance
Review logbooks, equipment records, and supporting documentation for accuracy and completeness
Review audit trails for data integrity and ALCOA+ compliance
Confirm accurate documentation in LIMS, notebooks, and electronic systems
Ensure reviewed data meets cGMP and FDA/EMA regulatory requirements
Conduct timely and thorough review of data packages to support lot release, stability pulls, device testing, and method verification/validation activities
Identify discrepancies and document data review comments; work with QC analysts to resolve issues
Support OOS, OOT, deviations, and investigations by evaluating analytical or microbiological data for trends, anomalies, or root causes
Maintain audit-ready documentation status and participate in audits as a data review SME
Recommend and support improvements to data review workflows, documentation templates, LIMS interfaces, and data integrity practices
Participate in training efforts for analysts on proper documentation and data integrity
Support implementation or upgrades to electronic data systems, such as LIMS
Partner with QC Chemistry, Raw Materials, Analytical Development, QC Microbiology, QA, Manufacturing, Supply Chain, and Product Development groups
Communicate delays, data discrepancies, and potential risks to QC and QA leadership promptly
Support cross-functional data requests related to product release, investigations, validations, or regulatory submissions
Qualification
Required
Bachelor's degree in Chemistry, Microbiology, Biochemistry, Biology, or related scientific discipline
3–5 years of experience in a Quality Control laboratory (analytical or microbiology) within biotech, pharmaceutical, or medical device industries
Strong working knowledge of cGMP, GLP, and data integrity expectations (ALCOA+)
Experience reviewing laboratory data for accuracy and compliance
Experience reviewing analytical chemistry and microbiology data (bioburden, endotoxin, EM trending, sterility)
Familiarity with chromatography software (e.g., Empower) and microbiology testing documentation
Proficiency with electronic data management systems, including LIMS
Preferred
Prior experience with method validation and stability study protocols is a plus
Company
Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to redefining the retina experience across drug development, treatment, and outcomes.
51-200 employees
H1B Sponsorship
Ocular Therapeutix, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (1)
2023 (3)
2022 (4)
2021 (10)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.19BKey Investors
Ascension VenturesPolaris Partners
2025-09-30Post Ipo Equity· $475M
2024-02-22Post Ipo Equity· $325M
2023-12-13Post Ipo Equity· $115.11M
Leadership Team
Pravin Dugel
Executive Chair, President, and CEO
Michael Goldstein
Chief Strategy Advisor
Recent News
2026-01-24
2026-01-23
2026-01-23
Company data provided by crunchbase