New · posted Oct 15
Kiniksa Pharmaceuticals International · Pharmaceuticals
Quality Control Specialist
- Lexington, MA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The 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
What you need
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
$72,000 – $91,500 a year
Employer provided$72,000—$91,500 USD
Where you'll work
Lexington, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Lexington, MAEqual opportunity, accessibility and legal noticesKiniksa Pharmaceuticals International's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 36% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in Massachusetts22 roles publishing pay
Associate & Specialist roles in the US100 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $72,000 | — | $91,500 |
| Massachusetts (middle half) | $61,250 | $73,500 | $87,625 |
| All US (middle half) | $49,375 | $60,000 | $76,125 |
This role: Kiniksa Pharmaceuticals International's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Kiniksa Pharmaceuticals International's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods16
- GMP and compliance7
- Documentation and SOPs6
- Collaboration and leadership5
- Quality systems and risk3
- Data and digital systems3
- Investigations and CAPA1
- Validation and qualification1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Kiniksa Pharmaceuticals International on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 1
- Locations
By discipline
- Quality4 80%
- Compliance & Safety1 20%
By level
- Director3 60%
- Senior & Principal1 20%
- Associate & Specialist1 20%
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Quality Control Specialist at Kiniksa Pharmaceuticals International
Open until filled. $72K–$92K a year, employer provided.