- 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, , archiving of documents 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.
- 3-5 years of experience in a regulated life science industry or other relevant experience.
- Bachelor's degree required. Advanced degree preferred.
- 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.
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Specialist/Sr. Specialist, Quality-Document Control and Training - Lexington, United States - Kiniksa Pharmaceutical
Description
Reporting to the Associate Director, Quality Management Systems, the Specialist/Sr.Specialist, Quality - Document Control and Training will be responsible for 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 GxP documents throughout their lifecycle and for supporting Kiniksa's Training Program.
This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Responsibilities (including, but not limited to):
Qualifications:
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.
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