Specialist, Quality – Document Control and Training

Reporting to the Associate Director, Quality Management Systems, the Specialist/Sr. 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.

Responsibilities (including, but not limited to):

• 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
• Support the operation and improvement of Kiniksa’s Training Program including adding Curriculum Assignments in LMS (Learning Management System), creating and distributing training reports, and partnering cross functionally to provide first line training support.
• Assist with execution of Test Scripts for validation testing of electronic quality systems and LMS enhancements.
• 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.
• Actively promote Kiniksa’s quality and compliance mindset throughout the organization by demonstrating the capabilities of the Training and Documentation Management Systems.

Standout Skills for Success:

• Detail oriented: Applies exceptional attention to detail to ensure accuracy, consistency, and compliance
• Collaborative: Partners cross-functionally to deliver seamless support for document management and training initiatives, reinforcing a culture of compliance
• Eager to learn: Highly motivated to learn and expand expertise in eDMS, LMS, and evolving quality processes
• Flexibility: Able to shift priorities as business dictates

Qualifications:

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