Quality Control Specialist
bydeluxe
Quality Control Specialist
kiniksapharmaceuticals· Quality Assurance
About this role
Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.
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
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$72,000—$91,500 USD
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. 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.
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.
Frequently Asked Questions
What is the salary for the Quality Control Specialist role at kiniksapharmaceuticals?
The listed salary for this Quality Control Specialist position at kiniksapharmaceuticals is USD 72K–92K. This is an full-time role.
Where is the Quality Control Specialist position at kiniksapharmaceuticals located?
This Quality Control Specialist role at kiniksapharmaceuticals is based in Lexington, MA. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Which team or department does the Quality Control Specialist at kiniksapharmaceuticals belong to?
This Quality Control Specialist position is part of the Quality Assurance department at kiniksapharmaceuticals. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Quality Control Specialist position at kiniksapharmaceuticals?
Click the "Apply Now" button on this page. You will be redirected to kiniksapharmaceuticals's official application portal hosted on greenhouse where you can submit your application directly.
When was the Quality Control Specialist job at kiniksapharmaceuticals posted?
This Quality Control Specialist position at kiniksapharmaceuticals was posted on Aug 4, 2026. Apply as soon as possible — early applications are often reviewed first.
Quality Control Specialist
kiniksapharmaceuticals · 💰 USD 72K–92K
You'll be redirected to kiniksapharmaceuticals's official application page on Greenhouse.