16 Specialist/Sr. Specialist, Quality-Document Control and Training Jobs in Lexington, MA
Kiniksa Pharmaceuticals is Hiring a Specialist/Sr. Specialist, Quality-Document Control and Training Near Lexington, MA
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)
- 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.
Job Summary
Full Time
Pharmaceutical
$69k-94k (estimate)
06/08/2024
07/23/2024
kiniksa.com
LEXINGTON, MA
100 - 200
2015
MICHAEL MEGNA
$10M - $50M
Pharmaceutical
Related Companies
About Kiniksa Pharmaceuticals
Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. We have an experienced team that has advanced multiple product candidates in parallel that focus on a range of debilitating diseases with significant unmet medical need. We continue to explore expanding our pipeline in order to develop life-changing medicines for patients who need it most. We are focused on hiring and retaining a highly skilled team that has extensive experience and ...specific skill sets relating to the selection, development, and commercialization of transformative therapies. Whether in development, research, manufacturing, technical operations, or general / administrative functions, we depend on a brilliant team to support our mission of building a global, generational company. Our benefits are competitive, and we offer dynamic career opportunities across our organization fostering a culture that embraces passion and rapid execution.
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