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Quality Control Stability Analyst Jobs in Massachusetts

Artech Information System LLC

QC Analyst

Devens, MA · On-site

$26.75 - $36/hr

Quality Control Analyst Location: Devens, MA Duration: 6 Months(extension up to 3 year) QC ... Routine testing and data review of batch release and stability samples of Bulk Drug Substance and ...

Integrated Resources INC

Quality Control Analyst

Lexington, MA · On-site

$27 - $36.25/hr

Client Direct Client Location Lexington, MA Job Title Quality Control Analyst Duration 1 Year+ Must have skill-set [ ] Responsibilities: Analyze samples using specific procedures and instrumentation.

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 ...

Veranova L P

Quality Control Analyst II

Devens, MA · On-site

$33/hr

The QC Analyst II will perform laboratory analysis and sampling of raw materials, intermediates, finished products, cleaning verification samples, stability samples and other miscellaneous samples ...

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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.

Quality Control Specialist

Kiniksa Pharmaceuticals

Lexington, MA

Full-time

Posted 29 days ago

Job description

Reporting to the Associate Director, Quality Control - Stability and Trending, the Stability Coordinator manages the GMP stability programs, supporting trending of methods, reference standard, and stability data to improve process and product understanding, and to support problem solving and decision making.  The successful candidate will support clients across Kiniksa, including Analytical Development, Quality Control, Manufacturing, CMC, Validation, and Quality Systems. 

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities (including, but not limited to):

  • Oversee systems supporting GMP stability programs including tracking and trending of stability data, generation of protocols and reports, and driving timely completion of quality records
  • Maintain stability testing records and results within the stability software to assure traceability and availability of records
  • Collaborate with contract laboratories to ensure timely completion of testing and delivery of QC deliverables for stability programs
  • Review and approve laboratory data and results, ensuring their traceability and integrity
  • Generate and present stability metrics to support annual reports, regulatory filings, and internal decision-making
  • Perform routine trending of stability data to support shelf-life of GMP products
  • Evaluate product stability data to establish and extend product shelf-life
  • Coordinate shipping and sample management of routine and non-routine testing activities
  • Drive process improvements and ensure inspection readiness (ISO, GMP alignment) for area of responsibility
  • Create and improve procedures related to GMP stability programs
  • Support batch certificate and Certificates of Analyses generation and additional tasks as required
  • Participate in the authoring and review of QC protocols and stability reports

Standout Skills for Impact:

  • Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CTLs
  • Proactive, with a strong desire to engage with clients, and act with urgency and passion
  • Strong ownership mindset with the ability to drive timelines and resolve issues in collaboration with internal teams and external partners
  • Ability to translate stability data and trends into clear insights that support decision-making, regulatory strategy, and product lifecycle management

Qualifications and Experience:

  • BS in a scientific area with 3-5 years of experience in Quality Control in a GMP setting
  • Working knowledge of statistical tools, methodologies, and related software, including experience with JMP as a plus
  • Experience working with contract testing laboratories or external vendors in a regulated environment
  • Ability to review analytical data for completeness, accuracy, traceability, and compliance with applicable procedures
  • Effective verbal and written communication skills
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail
  • Familiarity with ICH stability guidelines and expectations for pharmaceutical products
  • Knowledge of quality systems and domestic and international regulatory requirements
 

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