Quality Systems Co-op

<div class="content-intro"><p>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.</p></div><p><span class="TextRun SCXW21865173 BCX0" lang="EN-US" data-contrast="none"><strong><span class="NormalTextRun SCXW21865173 BCX0">Job Summary</span><span class="NormalTextRun SCXW21865173 BCX0">:</span></strong><span class="NormalTextRun SCXW21865173 BCX0"> </span><span class="NormalTextRun SCXW21865173 BCX0">Responsible for </span><span class="NormalTextRun SCXW21865173 BCX0">supporting </span><span class="NormalTextRun SCXW21865173 BCX0">compliant implementation</span><span class="NormalTextRun SCXW21865173 BCX0"> and </span><span class="NormalTextRun SCXW21865173 BCX0">continual improvement</span><span class="NormalTextRun SCXW21865173 BCX0"> of quality</span><span class="NormalTextRun SCXW21865173 BCX0"> activities such as </span><span class="NormalTextRun SCXW21865173 BCX0">daily </span><span class="NormalTextRun SCXW21865173 BCX0">use of </span><span class="NormalTextRun SCXW21865173 BCX0">integrated electronic systems</span><span class="NormalTextRun SCXW21865173 BCX0">, specifically the </span><span class="NormalTextRun SCXW21865173 BCX0">electronic Document Management System (</span><span class="NormalTextRun SpellingErrorV2Themed SCXW21865173 BCX0">eDMS</span><span class="NormalTextRun SCXW21865173 BCX0">)</span><span class="NormalTextRun SCXW21865173 BCX0"> for documents/records</span><span class="NormalTextRun SCXW21865173 BCX0"> and </span><span class="NormalTextRun SCXW21865173 BCX0">electronic Learning Management System (</span><span class="NormalTextRun SpellingErrorV2Themed SCXW21865173 BCX0">eLMS</span><span class="NormalTextRun SCXW21865173 BCX0">)</span><span class="NormalTextRun SCXW21865173 BCX0"> for training and qualifications</span><span class="NormalTextRun SCXW21865173 BCX0">, and use of applicable Quality Management Systems (QMS)</span><span class="NormalTextRun SCXW21865173 BCX0">. </span><span class="NormalTextRun SCXW21865173 BCX0">As part of </span><span class="NormalTextRun SCXW21865173 BCX0">willingness to learn, strong organizational skills and strong interpersonal skills</span><span class="NormalTextRun SCXW21865173 BCX0">, </span><span class="NormalTextRun SCXW21865173 BCX0">act</span><span class="NormalTextRun SCXW21865173 BCX0"> as cross-functional partner by providing guidance and support</span><span class="NormalTextRun SCXW21865173 BCX0"> to ensure teams across </span><span class="NormalTextRun SCXW21865173 BCX0">the company</span><span class="NormalTextRun SCXW21865173 BCX0"> use these systems effectively</span><span class="NormalTextRun SCXW21865173 BCX0">.</span></span></p> <p><strong><span data-contrast="none">Primary Responsibilities</span></strong><span data-ccp-props="{"201341983":0,"335551550":1,"335551620":1,"335559738":30,"335559739":30,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Document Management & Control- Collaborating closely, directly supporting, and guided by Senior Manager, Quality Systems & Compliance in the execution of the following:</span> <ul> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Provide support and oversight for the Document Management & Control system and ensuring compliance with requirements.</li> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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.</li> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">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.</li> </ul> </li> <li>Training, Learning & Qualification- Collaborating closely, directly supporting, and guided by Senior Manager, Quality Systems & Compliance in the execution of the following: <ul> <li><span data-contrast="none">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.</span></li> <li>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.</li> <li>Gap analysis for training items as continuous improvements to the training program progress.</li> </ul> </li> <li>Work with QS&C (Quality Systems & Compliance) team and data owners to upload/process documents via an approved protocol.</li> </ul> <p><strong><span data-contrast="none">Core Competencies (Required Skills)</span></strong><span data-ccp-props="{"201341983":0,"335551550":1,"335551620":1,"335559738":30,"335559739":30,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Familiar with Document Control/Records Management requirements</span></li> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Technical and scientific writing and presentation skills</li> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Highly organized, collaborative, right & positive attitude, compliant, entrepreneurial, and action-oriented mindset is a plus</li> </ul> <p><strong><span data-contrast="none">Preferred Skills</span></strong><span data-ccp-props="{"201341983":0,"335551550":1,"335551620":1,"335559738":30,"335559739":30,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">E</span><span data-contrast="none">xperience with Microsoft suite of applications</span></li> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Familiarity with integrated electronic systems such as an eDMS or an eLMS is a plus</span></li> </ul> <p><strong><span data-contrast="none">Education Requirements</span></strong><span data-ccp-props="{"201341983":0,"335551550":1,"335551620":1,"335559738":30,"335559739":30,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Currently enrolled in Computer Science, Biological Sciences, Engineering or related programs</span></li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>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.<strong><em> </em></strong></p></div><div class="title">Potential base pay range</div><div class="pay-range"><span>$28</span><span class="divider">—</span><span>$32 USD</span></div></div></div><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: 'trebuchet ms', geneva, sans-serif;"><strong><img style="max-width: 100%;" alt=""> <a href="https://diversityjobs.com/employer/top-diversity-employers?utm_campaign=TopEmployer&utm_medium=badge"> <img style="max-width: 100%;" src="https://diversityjobs.com/imglib/employer-images/2023/employer-member.png" alt="DiversityJobs.com Employer Member" width="174"></a> </strong></span></p> <p><span style="font-size: 12pt; font-family: 'trebuchet ms', geneva, sans-serif;"><strong>Our Diversity, Equity & Inclusion Mission Statement:</strong><strong>  </strong>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.</span></p> <p><span style="font-size: 10pt; font-family: 'trebuchet ms', geneva, sans-serif;"><em>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.</em></span></p> <p><span style="font-size: 10pt; font-family: 'trebuchet ms', geneva, sans-serif;"><em><strong>Recruitment & Staffing Agencies:<br></strong>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.</em></span></p></div>