Quality Assurance Specialist - Data Integrity & Compliance

Charles River Laboratories; Singapore; On-site; SGD 42,000 - 65,000; Full time

Job summary

Charles River Laboratories is seeking a detail‑oriented records/QA specialist to ensure timely archiving, data integrity and compliant documentation across quality systems.

The role involves supporting sponsor site visits, regulatory inspections, change management, CAPA monitoring, and release activities for tests, reagents and facilities, with emphasis on accuracy and adherence to global SOPs.

Qualifications

• Education: Life Science Diploma, Bachelor’s degree or equivalent.
• Some experience with Microsoft Office® applications. Position requires the individual to be able to communicate clearly, effectively and professionally; easily grasp instructions without follow-up; attention to detail and strong writing skills are essential.
• Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.

Responsibilities

• Responsible for timely archiving or records, checking for good documentation practices and data integrity.
• Participate in the preparation of records and QA files in preparation for sponsor site visits and regulatory inspections. May participate in the support of client site visits.
• Supports change management processes including monitoring of activities, action verification and its due date and working closely with other departments to ensure timely completion of actions.
• Supports the quality system operations such as monitoring of investigation due dates, CAPAs, Internal audit completion, test protocol approvals and working with other department to ensure timely closure or extension.
• Review quality records such as logbooks and manage its issuance.
• Approve customer test reports and participate in reagent, equipment and facility release activities to support laboratory operations.
• Assist in monitoring and verifying training and document management activities.
• Performs all functions as tasked with high degree of accuracy and strict adherence to company’s quality requirements.
• Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, Company global SOPs and data integrity principles for all activities.
• Assists in quality system projects that involved system implementation for cGMP compliance

Skills

Microsoft Office

Education

Life Science Diploma

Bachelor’s degree or equivalent

Job description

Charles River Laboratories is seeking a detail‑oriented records/QA specialist to ensure timely archiving, data integrity and compliant documentation across quality systems.

The role involves supporting sponsor site visits, regulatory inspections, change management, CAPA monitoring, and release activities for tests, reagents and facilities, with emphasis on accuracy and adherence to global SOPs.