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Quality Control Stability Analyst Jobs in Rhode Island

Amgen, Inc.

Specialist QC

West Greenwich, RI · On-site

Analytical Investigation Ownership * Lead Quality Control analytical investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, and unexpected analytical results. * Perform ...

Amgen

Specialist QC

West Greenwich, RI · On-site

Analytical Investigation Ownership * Lead Quality Control analytical investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, and unexpected analytical results. * Perform ...

Amgen SA

Specialist QC

West Greenwich, RI · On-site

$95 - $125/hr

Analytical Investigation Ownership * Lead Quality Control analytical investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, and unexpected analytical results. * Perform ...

Amgen

Quality Control Associate

West Greenwich, RI · On-site

Responsible for one or more of the following activities in Quality Control including analytical testing, characterization, sample and data management * Perform sample collection and sample handling ...

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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 Rhode Island?

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

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

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

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

Cities in Rhode Island 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 Rhode Island as of June 2026, with employment types broken down into 98% Full Time, and 2% Part Time. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Specialist QC

West Greenwich, RI • On-site

Amgen, Inc.
See more jobs at Amgen, Inc.external

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 14 days ago

Job description

Career Category
Operations
Job Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Specialist QC
What you will do
Let's do this. Let's change the world. In this vital role you will support analytical investigations ownership within the QC Technical Services team at Amgen.
Responsibilities:
Analytical Investigation Ownership
  • Lead Quality Control analytical investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, and unexpected analytical results.
  • Perform scientifically sound root cause analysis and develop effective corrective and preventive actions (CAPAs).
  • Ensure investigations are completed accurately, on time, and in compliance with GMP requirements and internal quality standards.

Quality Systems & Risk Assessment
  • Own and support deviations, CAPAs, and effectiveness verifications as assigned.
  • Review and approve equipment-related change controls, as applicable.
  • Partner with Quality Assurance to ensure investigation outcomes are risk-based and inspection-ready.
  • May support additional project-based assignments as required.

Cross-Functional Collaboration
  • Collaborate with Quality Control laboratories, Manufacturing, Process Development, Quality Assurance, Supply Chain, and other functional groups to resolve complex quality events.
  • Facilitate effective communication among stakeholders to ensure timely investigation progression and issue resolution.
  • Engage subject matter experts as needed to support technically complex investigations.

Inspection Readiness
  • Support internal and external audits by clearly communicating investigation findings, root cause, and CAPA effectiveness.
  • Maintain complete, accurate, and inspection-ready documentation.

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative teammate with these qualifications.
Basic Qualifications
  • High school diploma/GED and 10 years of directly related experience OR
  • Associate's degree and 8 years of directly related experience OR
  • Bachelor's degree and 4 years of directly related experience OR
  • Master's degree and 2 years of directly related experience OR
  • Doctorate degree

Preferred Qualifications
  • Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or another Life Science discipline.
  • 5-8+ years of Quality Control or Quality Assurance experience within the biotechnology or pharmaceutical industry.
  • Demonstrated experience leading complex laboratory investigations, including OOS, OOT, atypical results, and laboratory deviations.
  • Strong knowledge of GMP regulations, laboratory quality systems, and deviation management processes.
  • Experience performing root cause analysis using structured problem-solving methodologies.
  • Strong understanding of analytical laboratory techniques, instrumentation, and data integrity principles.
  • Experience authoring and managing deviations, CAPAs, change controls, and effectiveness verifications.
  • Ability to evaluate technical data, assess risk, and make sound, science-based decisions.
  • Strong written and verbal communication skills with the ability to influence cross-functional teams.
  • Experience supporting regulatory inspections and responding to auditor inquiries.
  • Experience utilizing digital tools, data analytics, or AI-enabled technologies to improve laboratory processes is preferred.

What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Salary Range
100,450.45USD -135,903.55 USD

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