Quality Control Specialist

Quality Control Specialist Lexington, MA

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.