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Quality Control Stability Analyst Jobs in Massachusetts

Dyne Therapeutics

Director, Quality Control

Waltham, MA · On-site

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

Lancesoft INC

Quality Control Analyst

Lexington, MA · On-site

$35 - $37/hr

This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing. * In this role, the ...

Artis BioSolutions

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 ...

LGC Group

Quality Control Analyst I

Milford, MA

$26.25 - $35.25/hr

Produce and use control charts. Perform tracking and trend analysis on laboratory data. * Performs quality control duties including, but not limited to; daily temperature log entries, emptying ...

LGC Group

Quality Control Analyst I

Milford, MA · On-site

$26.25 - $35.25/hr

Produce and use control charts. Perform tracking and trend analysis on laboratory data. * Performs quality control duties including, but not limited to; daily temperature log entries, emptying ...

LGC Group

Quality Control Analyst I

Milford, MA

$26/hr

Produce and use control charts. Perform tracking and trend analysis on laboratory data. * Performs quality control duties including, but not limited to; daily temperature log entries, emptying ...

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All JobsQuality Control Stability Analyst JobsQuality Control Stability Analyst Jobs in Massachusetts

Quality Control Stability Analyst information

What is a quality control stability analyst?

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?

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 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 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.

How much does a quality control stability analyst earn?

A quality control stability analyst typically earns between $50,000 and $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 stability testing, laboratory skills, and regulatory standards.

What are popular job titles related to Quality Control Stability Analyst jobs in Massachusetts?

For Quality Control Stability Analyst jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Quality Control Stability Analyst jobs in Massachusetts look for?

The top searched job categories for Quality Control Stability Analyst jobs in Massachusetts are:

What cities in Massachusetts are hiring for Quality Control Stability Analyst jobs?

Cities in Massachusetts with the most Quality Control Stability Analyst job openings:

Quality Control Stability Analyst jobs near you
Infographic showing various Quality Control Stability Analyst job openings in Massachusetts as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 17% Part Time, 4% Contract, and 1% Nights. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Director, Quality Control

Dyne Therapeutics

Waltham, MA • On-site

Full-time

Re-posted 29 days ago

Job description

Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and commercial stages. Provides strategic direction and operational leadership to ensure compliant, efficient, and high-quality execution of QC activities from early development through BLA and commercialization. Drives cross-functional alignment and external partnership performance while shaping the QC function to meet evolving organizational and regulatory requirements.
This is an onsite role based in Waltham, MA.
Primary Responsibilities Include:
Quality Control Strategy & Functional Leadership
  • Defines and executes the strategic vision for the Quality Control function to support clinical and commercial programs
  • Establishes organizational structure, capabilities, and processes to support growth and future commercialization
  • Participates in Pharmaceutical Quality leadership team activities, contributing to functional goals, priorities, and budgets
  • Leads and develops QC personnel, including oversight of training, performance, and team development

External Laboratory Oversight & Analytical Operations
  • Oversees external QC laboratories, including testing execution, data analysis, and issuance of Certificates of Analysis
  • Defines, tracks, and trends laboratory performance metrics (e.g., quality, capacity, turnaround time, non-conformances) to drive partner accountability and continuous improvement
  • Leads analytical troubleshooting efforts in collaboration with contract laboratories
  • Ensures alignment of external partners with program timelines to enable product disposition

Quality Systems, Compliance & Technical Execution
  • Reviews and approves analytical method qualification and validation protocols and reports
  • Authors, reviews, and approves stability protocols and reports and supports assignment of product expiry
  • Supports establishment of critical quality attributes (CQAs) and product specifications for Drug Substance (DS) and Drug Product (DP)
  • Partners with QA to ensure effective oversight of cGMP QC activities, including change control, deviations, investigations, CAPAs, and batch disposition support
  • Leads Out of Specification (OOS) and Out of Trend (OOT) investigations
  • Authors, reviews, and approves QC standard operating procedures

Regulatory, Inspection Readiness & Cross-Functional Collaboration
  • Prepares and reviews analytical CMC content for regulatory submissions (INDs, BLAs) and supports interactions with global health authorities
  • Participates in regulatory inspections and ensures inspection readiness across QC activities
  • Collaborates closely with Quality Assurance, Manufacturing, CMC, Supply Chain, Regulatory Affairs, and Project Management to align quality and program objectives
  • Oversees stability and reference standard programs to ensure compliance with regulatory expectations

Education and Skills Requirements:
  • Bachelor's degree in Biology, Biochemistry, Chemistry, or related discipline; advanced degree (PhD) in Chemistry or Analytical Chemistry strongly preferred
  • 12+ years of experience in Analytical Development and/or Quality Control within a GMP-regulated environment
  • Strong expertise in analytical techniques (e.g., SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA)
  • Deep knowledge of cGMP regulations and global guidance (FDA, ICH, EU)
  • Experience with compendial and product-specific analytical methods for biologics and/or small molecules
  • Demonstrated experience managing external QC laboratories and vendor performance
  • Experience supporting CMC regulatory submissions from IND through BLA and commercialization
  • Experience with oligonucleotide therapeutics, mass spectrometry, or bioanalytical assays is a plus
  • Proven leadership experience, including building and developing teams and driving organizational effectiveness
  • Strong strategic thinking and problem-solving capabilities with the ability to translate strategy into execution
  • Excellent interpersonal, communication, and negotiation skills with the ability to influence internal and external stakeholders
  • Highly collaborative leader who fosters cross-functional alignment and drives results in a fast-paced environment

#LI-Onsite
MA Pay Range
$190,000-$230,000 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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