graduate laboratory analyst.

The Product Support Investigator is responsible for logging, assessing the reportability of end-user complaints, and conducting investigations in accordance with site procedures and regulations.

Main Responsibilities:

• Log, acknowledge, and assess alleged product deficiencies from end users for adverse event reportability within specified timelines.
• Conduct thorough investigations to identify and report the cause of reported issues.
• Manage Supplier Corrective Actions (SCARS) received and ensure timely resolution.
• Contribute to continuous improvement initiatives and general housekeeping duties to enhance operational efficiency.
• Engage in ongoing professional development and site training initiatives.
• Foster excellent relations within the department team and broader Operations group to ensure effective collaboration.
• Propose ideas and initiatives to enhance communication and productivity within the team.
• Adhere to relevant policies and procedures outlined for the role.

Qualifications:
Education:

• Bachelor's degree in Biological Sciences or related field.

Experience/Background:

• Minimum 3 years of practical experience in an IVD (In Vitro Diagnostics) manufacturing environment.
• 3 years of experience within life sciences or similarly regulated industry, with exposure to In-Vitro Diagnostics preferred.
• Proficient in complaint logging and investigation of IVD product deficiencies per ISO 13485:2016 standards.
• Experience with complaint management software, with preference for SFDC.
• Proficient in Root Cause Analysis (RCA) tools, including A3/DMAIC methodologies.
• Ability to contribute to Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).
• Familiarity with Enterprise Resource Planning (ERP) systems and Electronic Document Management Systems (EDMS).
• Experience with Corrective and Preventive Action (CAPA) systems, with Agile experience preferred.
• Strong proficiency in MS Word, Excel, and PowerPoint.
• Hands-on experience running IVD tests such as Immunoassay and Clinical Chemistry.

Note: Preferred qualifications are indicated where applicable.

Randstad Business Support is acting as an Employment Business in relation to this vacancy.