Senior Associate, QA

Maze Therapeutics•South San Francisco, CA

2d•Hybrid

About The Position

The Position The Qu ality Assurance team is seeking a Senior Associate , Q uality Assurance, to help optimize the q uality systems and programs . In this role, you will manage the day -to-day activities related to the Document Control and GxP Training programs . This position requires cross-functional collaboration to ensure processes are completed accurately and within established timelines , while identifying opportunities to improve efficiency . This position will report to the Senior QA Manager. The Impact You’ll Have Document Control Management : Collaborate closely with stakeholders to develop, format, and maintain controlled documents and templates . Execute activities across the full document lifecycle management including creation, routing, review, approval, periodic review, and archiving to ensure completion, compliance and data integrity. Administer document ation (paper and electronic) issuance, reconciliation , and retention activities and ensur e proper archiving practices and efficient retrieval processes. Troubleshoot documen t-related issues within Microsoft Office applications (e.g., Word, Excel) and PDF software (e.g., Adobe Acrobat). Training Program : Contribute to GxP training initiatives across the organization, acting as a Subject Matter Expert (SME) for the training program . Ensure user roles, curriculum, and training items are developed, maintained , and assigned appropriately within the electronic Learning Management System ( ComplianceWire ) . Par ticipate in ComplianceWire maintenance and validation activities such as executing user test scripts during changes to the system . Monitor system performance , address technical issues and users need promptly to maintain system integrity and process efficiency . Coordinate onboarding activities of new GxP employees such as conducting training sessions and assign ing training in a timely manne r . QA Support and Continuous Improvement : Collaborate with QA and other stakeholders to support documentation, training, and quality system needs. Assist with deviations, CAPAs, change controls, and other quality system activities, as assigned. Participate in onsite audits and regulatory or client inspections, including preparation and readiness of documentation and training records. Contribute to continuous improvement initiatives related to quality systems, document management, and training processes. Manage tracking and reporting activities , related to . quality metrics Actively contributes to a collaborative and compliant quality culture. Perform other related duties as assigned to support QA operations.

Requirements

Bachelor’s degree or higher in a scientific discipline with 3+ years of relevant experience in a regulated environment, pre ferably in QA
Knowledge of Good Documentation Practices, ALCOA, and FDA, ICH, and international pharmaceutical regulations and guidelines.
E xperience supporting document management and/or GxP training activities.
E xperience administering ComplianceWire or other electronic Learning Management Systems.
Proficiency with Microsoft Office Suite (e.g., Word, Excel) and commonly used quality support tools (e.g., Adobe Acrobat, SharePoint, Docusign).
A ttention to detail with effective organizational and time management abilities
W ritten and verbal communication skills applicable to regulated documentation and cross‑functional coordination.

Nice To Haves

Experience with implementation and validation of an eQMS system for document management and/or quality processes is a plus
Demonstrated ability to work independently and collaboratively with cross-functional stakeholders.

Responsibilities

Collaborate closely with stakeholders to develop, format, and maintain controlled documents and templates
Execute activities across the full document lifecycle management including creation, routing, review, approval, periodic review, and archiving to ensure completion, compliance and data integrity.
Administer document ation (paper and electronic) issuance, reconciliation , and retention activities and ensur e proper archiving practices and efficient retrieval processes.
Troubleshoot documen t-related issues within Microsoft Office applications (e.g., Word, Excel) and PDF software (e.g., Adobe Acrobat).
Contribute to GxP training initiatives across the organization, acting as a Subject Matter Expert (SME) for the training program
Ensure user roles, curriculum, and training items are developed, maintained , and assigned appropriately within the electronic Learning Management System ( ComplianceWire )
Par ticipate in ComplianceWire maintenance and validation activities such as executing user test scripts during changes to the system
Monitor system performance , address technical issues and users need promptly to maintain system integrity and process efficiency
Coordinate onboarding activities of new GxP employees such as conducting training sessions and assign ing training in a timely manne r
Collaborate with QA and other stakeholders to support documentation, training, and quality system needs.
Assist with deviations, CAPAs, change controls, and other quality system activities, as assigned.
Participate in onsite audits and regulatory or client inspections, including preparation and readiness of documentation and training records.
Contribute to continuous improvement initiatives related to quality systems, document management, and training processes.
Manage tracking and reporting activities , related to . quality metrics
Actively contributes to a collaborative and compliant quality culture.
Perform other related duties as assigned to support QA operations.