Quality Control Specialist

Regulatory Jobs; Lexington (MA); On-site; USD 72,000 - 92,000; Full time

Job summary

Kiniksa Pharmaceuticals in Lexington, MA is seeking a Stability Coordinator to oversee GMP stability programs across Analytical Development, Quality Control, and Manufacturing. This onsite role drives trending, data integrity, protocol and report generation, and collaboration with contract labs to ensure QC deliverables and regulatory readiness.

The candidate will develop stability metrics, support annual reports, stability extensions, and QA documentation while maintaining traceability and

Qualifications

• 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.

Responsibilities

• Oversee GMP stability programs, tracking and trending of stability data, generation of protocols and reports, and timely completion of quality records.
• Maintain stability testing records and results within stability software to assure traceability of records.
• Collaborate with contract laboratories to ensure timely testing and delivery of QC stability deliverables.
• Review and approve laboratory data and results for 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 for GMP stability areas.
• Create and improve procedures related to GMP stability programs.
• Support batch certificates and Certificates of Analysis generation and other tasks as required.
• Participate in authoring and reviewing QC protocols and stability reports.

Skills

Project management

Cross-functional teams

Ownership mindset

Stability data interpretation

Education

BS in science

Tools

JMP

Job description

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 areprovidedreasonable accommodation toparticipatein 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.