Data Review Specialist, Quality Control
Ocular Therapeutix, Inc.
August 22, 2026
On-site
Bedford, MA
Operations
Position Summary
The Data Review Specialist will review analytical chemistry, microbiology, stability, and release testing data for accuracy, completeness, scientific soundness, and compliance with cGMP, GLP, and ALCOA+ expectations to support batch release, stability studies, environmental monitoring, method validation, and device testing.
Key Responsibilities
Quality Control Data Review
- Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance) for calculations, suitability, standards, sequences, and integration.
- Review microbiology data (bioburden, endotoxin, sterility, ID, EM, growth promotion, device-specific assays).
- Trend stability data across drug products, raw materials, and device-related attributes; identify atypical results, potential OOT signals, and patterns needing escalation.
- Support interpretation of stability data for timepoints, stability reports, annual product reviews, regulatory submissions, and lifecycle monitoring.
- Monitor released testing data for commercial/clinical batches (assay, impurities/degradation, dissolution/release, microbiological, and device performance).
- Collaborate to determine whether patterns require investigation, CAPA, procedural updates, or enhanced monitoring.
- Trend raw material data (lot variability, retest/expiry, CoA verification trends, recurring issues).
Documentation & Compliance
- Ensure data packages meet cGMP/GLP/FDA-EMA/internal SOP and data integrity expectations for lot release, stability, raw materials, device testing, method validation, and regulatory support.
- Identify/document discrepancies, atypical results, and potential data integrity concerns; resolve with QC/QA/originating groups.
- Support OOS/OOT/deviations/CAPAs/audits/APR-PQR inputs/regulatory requests by evaluating relevant data.
Quality Systems & Continuous Improvement
- Improve data review workflows, documentation templates, JPM, LIMS/Empower interfaces, and data integrity practices.
- Maintain reports/trackers/dashboards/KPIs for QC management review and product quality monitoring.
- Serve as a technical resource to QC analysts (documentation, audit trail review, ALCOA+, inspection readiness).
Cross-Functional Collaboration
- Partner with QC Chemistry, Raw Materials, Analytical Development, QC Microbiology, QA, Manufacturing, Supply Chain, and Product Development.
- Promptly communicate delays, discrepancies, and risks.
- Support data requests for release, investigations, validations, and regulatory submissions.
Qualifications
- Bachelor’s degree in Chemistry, Microbiology, Biochemistry, Biology, or related field.
- 5+ years in QC laboratory/data review or similar GMP-regulated environment with increasing responsibility.
- Strong knowledge of cGMP, GLP, and data integrity (ALCOA+).
- Ability to independently review data and collaborate to resolve issues.
- Experience reviewing analytical chemistry and microbiology data (bioburden, endotoxin, EM trending, sterility).
- Familiarity with Empower and microbiology testing documentation.
- Proficiency with JPM, LIMS, Smartsheets, and Empower.
- Statistical software familiarity (JMP preferred).
- Method validation and stability study experience is a plus.
The Data Review Specialist will review analytical chemistry, microbiology, stability, and release testing data for accuracy, completeness, scientific soundness, and compliance with cGMP, GLP, and ALCOA+ expectations to support batch release, stability studies, environmental monitoring, method validation, and device testing.
Key Responsibilities
Quality Control Data Review
- Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance) for calculations, suitability, standards, sequences, and integration.
- Review microbiology data (bioburden, endotoxin, sterility, ID, EM, growth promotion, device-specific assays).
- Trend stability data across drug products, raw materials, and device-related attributes; identify atypical results, potential OOT signals, and patterns needing escalation.
- Support interpretation of stability data for timepoints, stability reports, annual product reviews, regulatory submissions, and lifecycle monitoring.
- Monitor released testing data for commercial/clinical batches (assay, impurities/degradation, dissolution/release, microbiological, and device performance).
- Collaborate to determine whether patterns require investigation, CAPA, procedural updates, or enhanced monitoring.
- Trend raw material data (lot variability, retest/expiry, CoA verification trends, recurring issues).
Documentation & Compliance
- Ensure data packages meet cGMP/GLP/FDA-EMA/internal SOP and data integrity expectations for lot release, stability, raw materials, device testing, method validation, and regulatory support.
- Identify/document discrepancies, atypical results, and potential data integrity concerns; resolve with QC/QA/originating groups.
- Support OOS/OOT/deviations/CAPAs/audits/APR-PQR inputs/regulatory requests by evaluating relevant data.
Quality Systems & Continuous Improvement
- Improve data review workflows, documentation templates, JPM, LIMS/Empower interfaces, and data integrity practices.
- Maintain reports/trackers/dashboards/KPIs for QC management review and product quality monitoring.
- Serve as a technical resource to QC analysts (documentation, audit trail review, ALCOA+, inspection readiness).
Cross-Functional Collaboration
- Partner with QC Chemistry, Raw Materials, Analytical Development, QC Microbiology, QA, Manufacturing, Supply Chain, and Product Development.
- Promptly communicate delays, discrepancies, and risks.
- Support data requests for release, investigations, validations, and regulatory submissions.
Qualifications
- Bachelor’s degree in Chemistry, Microbiology, Biochemistry, Biology, or related field.
- 5+ years in QC laboratory/data review or similar GMP-regulated environment with increasing responsibility.
- Strong knowledge of cGMP, GLP, and data integrity (ALCOA+).
- Ability to independently review data and collaborate to resolve issues.
- Experience reviewing analytical chemistry and microbiology data (bioburden, endotoxin, EM trending, sterility).
- Familiarity with Empower and microbiology testing documentation.
- Proficiency with JPM, LIMS, Smartsheets, and Empower.
- Statistical software familiarity (JMP preferred).
- Method validation and stability study experience is a plus.