New · posted Oct 15
Ocular Therapeutix · Pharmaceuticals
Data Review Specialist, Quality Control
- Bedford, MA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
The Data Review Specialist will apply strong technical knowledge of laboratory operations, analytical data review, data integrity requirements, and quality systems to perform thorough reviews of analytical chemistry, microbiology, stability, and release testing data for accuracy, completeness, scientific soundness, and compliance with cGMP, GLP, and ALCOA+ expectations. This position is critical for supporting batch release, stability studies, environmental monitoring, method validation, and device testing.
In addition to data review, this role will support QC data monitoring activities, including evaluation of release data, raw material testing data, and stability data trends to identify emerging patterns, atypical results, potential OOT signals, and opportunities for improved product understanding. The Data Review Specialist will serve as a trusted partner to QC, QA, Stability, Manufacturing, Supply Chain, and Analytical Development stakeholders.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
What you need
- Bachelor’s degree in Chemistry, Microbiology, Biochemistry, Biology, or related scientific discipline.
- 5+ years in a QC laboratory, or data review role or a similar GMP-regulated environment, with a track record of strong performance, reliability, and increasing responsibility.
- Strong working knowledge of cGMP, GLP, and data integrity expectations (ALCOA+).
- Ability to independently review laboratory data, identify discrepancies, and collaborate effectively with peers and stakeholders to resolve issues in a timely manner.
- 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 JPM, LIMS, Smartsheets and Empower.
- Familiarity with statistical software, JMP preferred.
- Prior experience with method validation and stability study protocols is a plus.
What you'll do
Quality Control Data Review
- Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance testing) to ensure accuracy in calculations, instrument suitability, standards, sequences, and chromatographic integration.
- Review microbiology data (bioburden, endotoxin, sterility, ID, EM, growth promotion, device-specific assays)
- Review and support trending of stability data across applicable drug products, raw materials, and device-related attributes to identify emerging trends, atypical results, potential OOT signals, and data patterns requiring escalation.
- Assist with interpretation of stability data in support of timepoint completion, stability reports, annual product reviews, regulatory submissions, and product lifecycle monitoring.
- Support monitoring of released testing data for commercial and clinical batches, including review of assay, impurities/degradation products, dissolution/drug release, microbiological, and device performance data where applicable.
- Collaborate with QC Stability, Raw Materials, QA, Manufacturing, Supply Chain, and Analytical Development to evaluate data trends and determine whether observed patterns require investigation, CAPA, procedural updates, or enhanced monitoring.
- Support trending and monitoring of raw material data, including supplier lot-to-lot variability, retest/expiry data, CoA verification trends, and recurring analytical or documentation issues.
Documentation & Compliance
- Ensure reviewed data packages meet cGMP, GLP, FDA/EMA, internal SOP, ALCOA+, and data integrity expectations for lot release, stability, raw materials, device testing, method validation, and regulatory support. Conduct timely and thorough review of data packages to support lot release, stability pulls, device testing, and method verification/validation activities.
- Identify and document discrepancies, atypical results, potential data integrity concerns, and review comments; work with QC, QA, and originating groups to resolve issues in a timely manner.
- Support OOS, OOT, deviations, CAPAs, audits, APR/PQR inputs, and regulatory requests by evaluating analytical, microbiological, stability, release, and raw material data for trends, anomalies, or potential root causes.
Quality Systems & Continuous Improvement
- Recommend and support improvements to data review workflows, documentation templates, JPM, LIMS/Empower interfaces, Smartsheet trackers, and data integrity practices.
- Generate and maintain reports, trackers, dashboards, and KPIs to support QC management review, workload visibility, product quality monitoring, and continuous improvement initiatives.
- Serve as a technical resource to QC analysts by reinforcing best practices in documentation, audit trail review, ALCOA+ expectations, data monitoring, and inspection readiness
Cross-Functional Collaboration
- Work cross-functionally 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.
Pay
$98,000 – $113,000 a year
Employer provided$98,000—$113,000 USD
Where you'll work
Bedford, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Bedford, MAEqual opportunity, accessibility and legal noticesOcular Therapeutix's statements, word for word
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 76% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in Massachusetts22 roles publishing pay
Associate & Specialist roles in the US100 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $98,000 | — | $113,000 |
| Massachusetts (middle half) | $61,250 | $73,500 | $87,625 |
| All US (middle half) | $49,375 | $60,000 | $76,125 |
This role: Ocular Therapeutix's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Ocular Therapeutix's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods18
- Documentation and SOPs13
- Data and digital systems8
- Collaboration and leadership8
- GMP and compliance7
- Validation and qualification4
- Quality systems and risk4
- Investigations and CAPA3
- Regulatory submissions2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
Ocular Therapeutix on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Quality3 100%
By level
- Associate & Specialist2 67%
- Director1 33%
More roles at Ocular Therapeutix
- View role
Quality Control Analyst I, Raw Materials
Bedford, MAAssociate & SpecialistPharmaceuticals$68K
- View role
Associate Director, Validation
Bedford, MADirectorPharmaceuticals$188K
Similar Quality Control roles elsewhere
- View role
QC Physical Testing Analyst
LantheusBillerica, MAAssociate & SpecialistPharmaceuticals$72K–$107K
- View role
Quality Control Specialist
Kiniksa Pharmaceuticals InternationalLexington, MAAssociate & SpecialistPharmaceuticals$72K
- View role
Quality Control Analyst
SanofiFramingham, MAAssociate & SpecialistPharmaceuticals$57K–$76K
- View role
Quality Control Analyst
SanofiFramingham, MAAssociate & SpecialistPharmaceuticals$50K–$67K
Data Review Specialist, Quality Control at Ocular Therapeutix
Open until filled. $98K–$113K a year, employer provided.