Quality Control Specialist
- Pay
- $72,000 – $91,500 per year
- Location
- Lexington, MA · On-site
- Job type
- Full-time
- Level
- Mid-level
- Experience
- 3+ years
- Education
- Bachelor's degree
- Listed
- 30 days ago
Skills & highlights for this role
- GMP
- stability testing
- ICH stability guidelines
- JMP
Also useful
- contract laboratory management
- statistical analysis
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
Additional information
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 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.
About Kiniksa Pharmaceuticals
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.
Equal opportunity and legal notices
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.
From Kiniksa Pharmaceuticals's careers page, first listed on Rolev.ai on October 10, 2026. Rolev.ai is not the employer.
How Rolev.ai helps with this application
Rolev.ai is a job search and application tool for US job seekers. For this Quality Control Specialist role at Kiniksa Pharmaceuticals, it shows how your resume fits, tailors your resume to the posting, and prepares the application for you to review.
See how you fit
Openings from employer career sites are ranked against your whole resume—and searchable inside Claude, ChatGPT, and Cursor via Rolev.ai MCP.
Tailor without inventing
Every change to your resume is checked against your original. New experience goes in only with your yes—zero fabricated claims.
Draft the full kit
Tailored and Full Match resumes, role-specific cover letters, and answers to employer screening questions are prepared in seconds.
1-Click Extension Autofill
The Chrome extension fills the employer's Greenhouse, Workday, Lever, or Ashby form in 1 click. You review it and press Submit.
Common questions
What is the salary for the Quality Control Specialist role at Kiniksa Pharmaceuticals?
The Quality Control Specialist posting at Kiniksa Pharmaceuticals states compensation of $72,000 – $91,500 per year. It is listed as a full-time position. Final pay may depend on location, experience, and interview evaluation on Kiniksa Pharmaceuticals's official career site.
Where is the Quality Control Specialist job at Kiniksa Pharmaceuticals located?
This Quality Control Specialist position at Kiniksa Pharmaceuticals is located in Lexington, MA (On-site). Always check Kiniksa Pharmaceuticals's application page for specific state eligibility or relocation policies.
What qualifications are required for Quality Control Specialist at Kiniksa Pharmaceuticals?
For the Quality Control Specialist role, Kiniksa Pharmaceuticals highlights 3+ years of relevant experience; a bachelor's degree; experience with GMP, stability testing, ICH stability guidelines, JMP. Rolev.ai can score your existing resume against these requirements and show any skill gaps before you apply.
How do I apply for the Quality Control Specialist position at Kiniksa Pharmaceuticals?
This listing links directly to Kiniksa Pharmaceuticals's Greenhouse application page. You can apply directly on Kiniksa Pharmaceuticals's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Greenhouse application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.