QA Specialist (Document Control)

Madrid12h ago

About the role

<div class="content-intro">About our Company:  Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers. </div>The Opportunity:  Universal DX is seeking a QA Specialist with strong expertise in document control and eQMS operations to join our growing Quality team. In this role, you will work closely with the QA Manager and other QA Specialists to ensure the accuracy, compliance, and continuous improvement of our global Quality Management System. You will play a key role in performing global document reviews, managing end‑to‑end eQMS processes, maintaining regulatory standards and requirements, overseeing training activities, and developing key quality metrics, between others. Your contribution will directly support the execution of our Quality strategy and enable the company’s growth and expansion in the Life Sciences sector, particularly across the USA and the EU.  You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.    How you’ll contribute:  <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Perform comprehensive global document reviews to ensure accuracy, compliance, and alignment with applicable standards prior to formal approval. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Manage the end‑to‑end administration of the electronic Quality Management System (eQMS), ensuring data integrity, proper documentation lifecycle control, and timely execution of quality processes. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Coordinate document updates, revisions, and version control activities with global stakeholders to maintain consistency and regulatory compliance. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Monitor and maintain eQMS workflows to support effective change control, training, and other quality‑related processes. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Develop, track, and report key quality metrics to support performance monitoring and continuous improvement initiatives. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Conduct gap assessments to identify compliance risks, improvement opportunities, and alignment with internal and external quality and regulatory requirements. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Manage global standards and other regulatory or quality requirements to ensure the organization maintains up‑to‑date and compliant documentation. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Oversee training requirements within the eQMS, ensuring proper assignment, timely completion, and accurate training records. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="41" data-list-defn-props="{"335551671":0,"335552541":1,"335559685":630,"335559991":360,"469769226":"Cambria","469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Serve as a central point of contact for document control and eQMS‑related queries, offering guidance and support to cross‑functional teams. </li> </ul>   What you’ll bring:  <ul> <li data-leveltext="•" data-font="Cambria" data-listid="26" data-list-defn-props="{"134224900":false,"335551671":0,"335552541":1,"335559685":860,"335559991":360,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="0" data-aria-level="1">Master's degree in Quality Management Systems. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="26" data-list-defn-props="{"134224900":false,"335551671":0,"335552541":1,"335559685":860,"335559991":360,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Bachelor’s degree. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="26" data-list-defn-props="{"134224900":false,"335551671":0,"335552541":1,"335559685":860,"335559991":360,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Minimum 2 years of experience as quality consultant or quality specialist. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="26" data-list-defn-props="{"134224900":false,"335551671":0,"335552541":1,"335559685":860,"335559991":360,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Good communication skills in English, both spoken and written. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="26" data-list-defn-props="{"134224900":false,"335551671":0,"335552541":1,"335559685":860,"335559991":360,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Constancy, effort, patience and perseverance. </li> </ul> <ul> <li data-leveltext="•" data-font="Cambria" data-listid="26" data-list-defn-props="{"134224900":false,"335551671":0,"335552541":1,"335559685":860,"335559991":360,"469769242":[8226],"469777803":"left","469777804":"•","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Be consistent, committed, competent, responsible and organized. </li> </ul>   What we offer:   <ul> <li>22 days of PTO.</li> <li>PTO on your Birthday.</li> <li>Flexible work schedule.</li> <li>Remote work opportunities.</li> <li>Flexible Remuneration with our partner Cobee.</li> </ul>    <div class="content-conclusion"> Why Now?  This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.   We are looking for passionate changemakers to be a part of our journey in this expansive time for us. </div>

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