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Quality Control Stability Analyst Jobs in Boston, MA

Dyne Therapeutics

Director, Quality Control

Waltham, MA · On-site

$190K - $230K/yr

The Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and ...

Landmark Bio

QC Analyst 1

Watertown, MA · On-site

$26 - $35/hr

The Quality Control - Analytics department supports a growing portfolio of cell and gene therapy (CGT) products, including CAR-T, iPSC, AAV, LVV and synthetic DNA products. We are immediately ...

Landmark Bio

QC Analyst 1

Watertown, MA

$26 - $35/hr

The Quality Control - Analytics department supports a growing portfolio of cell and gene therapy (CGT) products, including CAR-T, iPSC, AAV, LVV and synthetic DNA products. We are immediately ...

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All JobsQuality Control Stability Analyst JobsQuality Control Stability Analyst Jobs in Boston, MA

Quality Control Stability Analyst information

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How much do quality control stability analyst jobs pay per hour?

As of Aug 1, 2026, the average hourly pay for quality control stability analyst in Boston, MA is $30.33, according to ZipRecruiter salary data. Most workers in this role earn between $25.05 and $33.70 per hour, depending on experience, location, and employer.

What are Quality Control Stability Analysts?

Quality Control Stability Analysts are professionals responsible for testing and evaluating the stability of pharmaceutical products over time. They design, conduct, and interpret experiments to ensure products maintain their safety, potency, and quality throughout their shelf life. Their work is crucial for regulatory compliance, as they document and report stability data according to industry standards and guidelines. These analysts often work in laboratory environments and collaborate closely with quality assurance and manufacturing teams.

What are the key skills and qualifications needed to thrive as a Quality Control Stability Analyst, and why are they important?

To thrive as a Quality Control Stability Analyst, you need a solid background in chemistry or related sciences, familiarity with Good Laboratory Practices (GLP), and often a relevant bachelor's degree. Experience with laboratory instrumentation such as HPLC, GC, and LIMS, along with knowledge of regulatory guidelines like ICH and FDA, is typically required. Attention to detail, strong organizational skills, and effective communication are critical soft skills in this role. These competencies ensure accurate data analysis, compliance with regulations, and reliable stability testing to maintain product quality and safety.

What is the difference between Quality Control Stability Analyst vs Quality Control Analyst?

AspectQuality Control Stability AnalystQuality Control Analyst
CertificationsGMP, GLP, relevant laboratory certificationsGMP, GLP, relevant laboratory certifications
Work EnvironmentPharmaceutical, biotech labs focusing on stability testingManufacturing labs, quality testing environments
Job FocusMonitoring product stability over time, data analysis for stability programsPerforming routine quality tests, raw material and finished product testing

The main difference is that a Quality Control Stability Analyst specializes in stability testing and data analysis related to product shelf life, while a Quality Control Analyst performs general quality testing. Both roles require similar certifications and work in related environments, but their focus areas differ within the quality assurance process.

Is QC analyst a stressful job?

A Quality Control Stability Analyst role can be stressful due to strict regulatory standards, the need for precision, and tight deadlines. The job often requires attention to detail, analytical skills, and familiarity with laboratory tools, which can contribute to work pressure but also offers a structured environment.

Is QC a high paying job?

Quality Control Stability Analysts typically earn salaries that are competitive within the manufacturing and pharmaceutical industries, with pay often increasing with experience and certifications. While not usually among the highest-paying roles, it can offer a stable income, especially for those with specialized skills or in regulated environments.

What does a quality control analyst do?

A quality control stability analyst monitors and evaluates the stability of pharmaceutical or manufacturing products over time to ensure they meet quality standards. They perform tests, analyze data, and document results, often using laboratory equipment and software, to confirm product consistency and compliance with regulations.

How much is the salary of a QA analyst?

The salary of a Quality Control Stability Analyst typically ranges from $50,000 to $80,000 annually, depending on experience, location, and industry. Entry-level positions may start lower, while experienced analysts with certifications can earn higher salaries. The role often requires knowledge of laboratory testing, stability studies, and regulatory compliance.

What are some typical challenges faced by Quality Control Stability Analysts, and how can they be addressed?

Quality Control Stability Analysts often face challenges such as managing multiple projects with tight timelines, accurately interpreting stability data, and ensuring compliance with stringent regulatory requirements. Balancing the need for meticulous documentation with the fast-paced nature of product development can also be demanding. To address these challenges, analysts benefit from strong organizational skills, effective communication with cross-functional teams (like R&D and production), and ongoing training on evolving industry standards and regulatory guidelines.
What are popular job titles related to Quality Control Stability Analyst jobs in Boston, MA? For Quality Control Stability Analyst jobs in Boston, MA, the most frequently searched job titles are:
What job categories do people searching Quality Control Stability Analyst jobs in Boston, MA look for? The top searched job categories for Quality Control Stability Analyst jobs in Boston, MA are:
Quality Control Stability Analyst jobs near you
Infographic showing various Quality Control Stability Analyst job openings in Boston, MA as of July 2026, with employment types broken down into 84% Full Time, and 16% Contract. Highlights an 96% In-person, and 4% Remote job distribution, with an average salary of $63,082 per year, or $30.3 per hour.

Data Review Specialist, Quality Control

Ocular Therapeutix

Bedford, MA • On-site

Full-time

Posted 3 days ago

New

Job description

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.
Position Summary:
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.
Key Responsibilities:
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.

Qualifications:
  • 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.

#LI-LM1
Salary Range
$98,000-$113,000 USD
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.

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