Senior Associate, QA at Maze Therapeutics

Description

<h3>The Position</h3> The Quality Assurance team is&nbsp;seeking&nbsp;a&nbsp;Senior Associate, Quality&nbsp;Assurance, to&nbsp;help&nbsp;optimize&nbsp;the&nbsp;quality&nbsp;systems and programs. In this role, you&nbsp;will manage&nbsp;the day-to-day&nbsp;activities related to&nbsp;the&nbsp;Document Control and&nbsp;GxP&nbsp;Training&nbsp;programs.&nbsp;This&nbsp;position&nbsp;requires cross-functional collaboration to ensure processes are completed&nbsp;accurately&nbsp;and within established timelines,&nbsp;while&nbsp;identifying opportunities to improve efficiency.&nbsp;This&nbsp;position will report to the Senior QA Manager.<span class="EOP TrackedChange SCXW213164362 BCX8" data-ccp-props="{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:300}">&nbsp; <h3>The Impact You’ll Have</h3> Document&nbsp;Control&nbsp;Management:&nbsp; <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Collaborate&nbsp;closely&nbsp;with stakeholders to develop, format, and&nbsp;maintain&nbsp;controlled documents and templates.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Execute activities across the&nbsp;full&nbsp;document&nbsp;lifecycle&nbsp;management&nbsp;including creation, routing, review, approval, periodic review, and archiving&nbsp;to ensure&nbsp;completion,&nbsp;compliance&nbsp;and data integrity.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Administer&nbsp;documentation&nbsp;(paper and electronic)&nbsp;issuance,&nbsp;reconciliation,&nbsp;and&nbsp;retention&nbsp;activities and&nbsp;ensure&nbsp;proper archiving practices and efficient retrieval processes.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="23" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Troubleshoot&nbsp;document-related&nbsp;issues within Microsoft Office applications (e.g., Word, Excel) and PDF software (e.g., Adobe Acrobat).&nbsp;</li> </ul> Training&nbsp;Program:&nbsp;&nbsp; <ul> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Contribute to GxP&nbsp;training initiatives across the organization, acting as a Subject Matter Expert (SME) for&nbsp;the&nbsp;training&nbsp;program.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Ensure&nbsp;user roles,&nbsp;curriculum, and&nbsp;training&nbsp;items are&nbsp;developed,&nbsp;maintained, and assigned appropriately within the electronic Learning Management System&nbsp;(ComplianceWire).&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Participate in&nbsp;ComplianceWire&nbsp;maintenance and&nbsp;validation&nbsp;activities&nbsp;such as&nbsp;executing&nbsp;user&nbsp;test scripts&nbsp;during changes to the system.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Monitor&nbsp;system&nbsp;performance,&nbsp;address technical&nbsp;issues&nbsp;and&nbsp;users need&nbsp;promptly to&nbsp;maintain&nbsp;system integrity and process efficiency.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="24" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1">Coordinate&nbsp;onboarding&nbsp;activities&nbsp;of&nbsp;new&nbsp;GxP&nbsp;employees&nbsp;such as conducting training sessions&nbsp;and&nbsp;assigning training&nbsp;in a timely manner.&nbsp;</li> </ul> &nbsp; QA Support&nbsp;and Continuous Improvement:&nbsp; <ul> <li data-leveltext="" data-font="Symbol" data-listid="25" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Collaborate with QA and other stakeholders to support documentation, training, and quality system needs.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="25" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Assist&nbsp;with deviations, CAPAs, change controls, and other quality system activities, as assigned.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="25" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Participate in&nbsp;onsite audits and regulatory or client inspections, including preparation and&nbsp;readiness&nbsp;of documentation and training records.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="25" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Contribute to continuous improvement initiatives related to quality systems, document management, and training processes.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="25" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1">Manage&nbsp;tracking and reporting&nbsp;activities,&nbsp;related to.quality metrics&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="25" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="6" data-aria-level="1">Actively&nbsp;contributes&nbsp;to a collaborative and compliant quality culture.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="25" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="7" data-aria-level="1">Perform other related duties as assigned to support QA operations.&nbsp;</li> </ul> <h3>What We’re Looking For</h3> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="1">Bachelor’s degree&nbsp;or higher&nbsp;in a scientific discipline with 3+ years of relevant experience&nbsp;in a regulated environment, preferably in QA.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="2" data-aria-level="1">Knowledge&nbsp;of Good Documentation Practices, ALCOA, and FDA, ICH, and international pharmaceutical regulations and guidelines.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="3" data-aria-level="1">Experience supporting document management and/or&nbsp;GxP&nbsp;training activities.&nbsp;&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="4" data-aria-level="1">Experience administering&nbsp;ComplianceWire&nbsp;or other electronic Learning Management Systems.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="5" data-aria-level="1">Proficiency&nbsp;with Microsoft Office Suite&nbsp;(e.g., Word, Excel)&nbsp;and commonly used quality support tools (e.g., Adobe Acrobat, SharePoint, Docusign).&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="6" data-aria-level="1">Experience with implementation and validation of an&nbsp;eQMS&nbsp;system for document management and/or quality processes is a plus.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="7" data-aria-level="1">Demonstrated ability to work independently and collaboratively with cross-functional stakeholders.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="8" data-aria-level="1">Attention to detail with&nbsp;effective&nbsp;organizational and time management&nbsp;abilities.&nbsp;</li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="21" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="9" data-aria-level="1">Written and verbal communication skills&nbsp;applicable to regulated documentation and cross‑functional coordination.&nbsp;</li> </ul> <h3>About Maze Therapeutics</h3> Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal,&nbsp;cardiovascular&nbsp;and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to&nbsp;identify&nbsp;and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which&nbsp;represents&nbsp;a novel precision medicine-based approach for chronic kidney disease.&nbsp;&nbsp;Maze is based in South San Francisco.&nbsp; <h3>Our People</h3> Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.&nbsp; Our Core Values Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.&nbsp; Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. <hr> The expected annual salary range for employees located in the San Francisco Bay Area is $126,000 - $154,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. &nbsp; #LI-Hybrid

Get notified about similar roles

Similar active positions

Senior Associate, QA

Description

Maze Therapeutics

Pipeline