Quality Systems Co-op

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.

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.

• Document Management & Control—Collaborating closely with Senior Manager, Quality Systems & Compliance in the execution of the following:
  • 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 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.
• Training, Learning & Qualification—Collaborating closely with Senior Manager, Quality Systems & Compliance in the execution of the following:
  • 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 team and data owners to upload/process documents via an approved protocol.

• 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

• Experience with Microsoft suite of applications
• Familiarity with integrated electronic systems such as an eDMS or an eLMS is a plus

• Currently enrolled in Computer Science, Biological Sciences, Engineering or related programs

This pay range represents the base hourly rate or base annual full‑time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors. Potential base pay range: $28—$32 USD.

Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex—including sexual orientation and gender identity—national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.