Quality Systems Co-op
About The Position
At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients. Job Summary: Responsible for supporting compliant implementation and continual improvement of quality activities such as daily use of integrated electronic systems, specifically the electronic Document Management System (eDMS) for documents/records and electronic Learning Management System (eLMS) for training and qualifications, and use of applicable Quality Management Systems (QMS). As part of willingness to learn, strong organizational skills and strong interpersonal skills, act as cross-functional partner by providing guidance and support to ensure teams across the company use these systems effectively.
Requirements
- Familiar with Document Control/Records Management requirements
- Technical and scientific writing and presentation skills
- Highly organized, collaborative, right & positive attitude, compliant, entrepreneurial, and action-oriented mindset is a plus
- Currently enrolled in Computer Science, Biological Sciences, Engineering or related programs
Nice To Haves
- Experience with Microsoft suite of applications
- Familiarity with integrated electronic systems such as an eDMS or an eLMS is a plus
Responsibilities
- Provide support and oversight for the Document Management & Control system and ensuring compliance with requirements.
- Participate, provide support for the initiation, review, and approval of applicable GxP documentation using the eDMS in collaboration with Functional Department personnel (e.g., Document Owner/Author) via performance of a Doc Control review and approval as required.
- Provide help and support to document initiator/owner and reviewers/approvers ensuring compliance with requirements and assists users with eDMS workflow and related issues when needed.
- Provide training administration support, review, approval of applicable training related contents in collaboration with Functional Area Head ensuring content and trainee eLMS transactions are processed and completed with requirements.
- Review and design report(s) to monitor and follow up on trainee progress, course and or training assignments, and assessment of training effectiveness and compliance.
- Gap analysis for training items as continuous improvements to the training program progress.
- Work with QS&C (Quality Systems & Compliance) team and data owners to upload/process documents via an approved protocol.
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What This Job Offers
Career Level
Intern
Education Level
No Education Listed
