Kiniksapharmaceuticals

Specialist, Quality – Document Control and Training

Lexington, MA · Senior

Sponsorship not specified$82k-$100kDetected 22 days ago

ExcelGMPFDA RegulatoryCommunicationMicrosoft OfficeSharePointGxP

About the role

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 Management Systems, the Specialist/Sr.

Support execution of document control activities including ensuring accuracy of information associated with Non-GxP and GxP documents, formatting of documents, verifying document references and issuing/reconciling Controlled Documents.
Provide end user support of business processes and electronic document management system (eDMS) navigation.
Support the document archive program including maintaining appropriate chain of custody for controlled documents submitted for archival, and maintaining the archive database.
Provide eDMS, Document Control and training support during Audits/Inspections
Act as the subject matter expert for the electronic document management systems, providing training/support to system users.
Develop and implement ways to simplify business processes and documentation strategies, to increase efficiency, ensure compliance, and reduce documentation maintenance requirements.
Collaborates cross-functionally to deliver seamless support for document management and training initiatives, reinforcing a culture of compliance

3-5 years of experience in a regulated life science industry or other relevant experience.
Bachelor's degree required.
Proven mindset of proactive continuous improvement.
Ability to work in a fast paced-environment and to handle multiple tasks.
Travel is not required for this role.
Direct experience in document control, quality systems and/or training.
Demonstrated strong written and verbal communication skills.
Efficient independent worker with ability to focus and drive for results.
Strong attention to detail.
Strong commitment to compliance and ethical standards.
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

Applies exceptional attention to detail to ensure accuracy, consistency, and compliance
Highly motivated to learn and expand expertise in eDMS, LMS, and evolving quality processes
Able to shift priorities as business dictates

$82,000 - $100,000 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.

decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

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.
Specialist, Quality - Document Control and Training will be responsible for a wide variety of activities pertaining to Document Control, Records Management, Training, and improving Kiniksa's Quality System.
This role will be responsible for the processing and maintaining of GxP documents throughout their lifecycle and for supporting Kiniksa's Training Program.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

This listing is sourced directly from Kiniksapharmaceuticals's careers page and normalized into a canonical job model.