Associate QA - Quality Management System (Tuas/1 Year Contract/Up to $3900)

The Associate QA (Quality Management System) supports the effective operation of Organization's Quality Management System, with primary responsibility for document management, records archival and retrieval, and related quality-system administration. This role contributes to accurate, timely and inspection-ready quality records; maintains reliable tracking and reporting tools; and works with site users and cross-functional partners to resolve routine operational issues. The Associate QA works closely with site users and cross-functional partners to resolve routine operational issues and provides assigned support for Learning & Performance, visual management, continuous improvement and digital initiatives. Through these responsibilities, the role helps strengthen compliance, operational efficiency and ensures seamless Quality operations for the site.

Key Responsibilities

Quality Management System and Document Management

Maintain oversight of document management and controlled-document workflows in Organization’s document management system, first-line user guidance and appropriate escalation of workflow issues.

Maintain accurate records in electronic archive system and prepare site-generated paper records for secure off-site storage, in accordance with applicable procedures, retention requirements and data-integrity expectations.

Maintain the archive room and associated inventory so records remain protected, traceable, orderly and readily retrievable.

Maintain signature logs and coordinate record retrieval, periodic review and approved destruction activities for business needs and inspection readiness, ensuring complete tracking, timely execution and follow-up on identified gaps.

Coordinate routine document-management administration, including archival supplies, service requests, purchase-order verification and other assigned operational tasks.

Support other QA activities as required by business needs, e.g., Participate in investigations as SME for Document

Management System; own or approve minor deviation, change controls, logbooks and other quality records, where applicable, and ensure that the systems are managed in compliance with cGMP expectations.

QMS Operations, Reporting and Inspection Readiness

Maintain department SharePoint sites, Smartsheet trackers, reference links, contact information and Quality Management System (QMS) metrics so that information, data and materials are accurate and readily available.

Support assigned QMS projects, audits and inspections by tracking actions, coordinating updates, retrieving records, following up on deliverables and maintaining clear documentation.

Partner with Digital, IT/network and QMS subject-matter experts to troubleshoot system or access issues and ensure appropriate escalation and resolution.

Participates in regulatory inspections and interact directly with regulatory inspectors during audits and inspections.

Drive continuous-improvement, standardized-work, 5S, visual-management or digital-innovation initiatives that improve quality-system efficiency, visibility or user experience.

Perform other duties or tasks assigned by immediate supervisor or HoD.

Learning & Performance Support (Secondary Scope)

Performs training-related assessments and partners with activity owners and managers to ensure that appropriate training strategy is applied.

Deliver training for staff and support Learning & Performance administrative activities as assigned.

Quality Excellence, Continuous Improvement and Digital Innovation Support (Secondary Scope)

Drive Continuous improvement and digital culture and initiative in Quality Function.

Support the development and maintenance of practical visual-management tools, dashboards or trackers for task, activity and project monitoring.

Education / Licenses

Degree in Science, Biotechnology, Biomedical Sciences or a related technical discipline; or

Diploma in Biomedical Sciences, Biotechnology or a related technical discipline, with two to three years of relevant work experience.

Relevant Experience

Experience in a regulated pharmaceutical, biotechnology, medical-device or similarly controlled environment is preferred.

Exposure to quality systems, document management, archival or records-management processes is preferred.

Experience supporting project coordination, metrics reporting, process improvement or administrative operations is an advantage.

Working knowledge of Microsoft Office applications; familiarity with SharePoint, Smartsheet, Veeva or Infolinx is an advantage.

Competencies / Skills

Compliance: Understand and apply GMP, data-integrity and inspection-readiness principles on daily work.

Organization and attention to detail: Maintains orderly, accurate and readily retrievable document-management records, archival processes and archive-room inventory.

Judgment, prioritization and improvement: Works independently, escalates appropriately and manages multiple activities while using data, trackers and visual tools to improve execution and visibility.

Communication and collaboration: Communicates clearly with users, providers and stakeholders, builds effective relationships and follows through across functions.

Technology Use: Comfortable working with, and quick to pick up new technology for practical use.

Additional Requirements

The role may require support outside routine working hours for audits, inspections, urgent record retrieval activities, in accordance with site needs and applicable policies

PERSOL Singapore Pte Ltd • UEN No. 200007268E • EA License No. 01C4394 • EA Registration No.R22109454 (Malcolm Lee Jun Hao)

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