QA Systems Specialist: CAPA, Documentation & Compliance

Thornton Tomasetti; Taguig; On-site; PHP 600,000 - 900,000; Full time

Job summary

Abbott is seeking a Quality Assurance Specialist in the CMI ARDx Cardiometabolic and Informatics division in Taguig, Philippines. You will support site QA activities, work on document control, training, complaints, CAPA, supplier control, and regulatory compliance.

The role requires a BS/BA in a scientific field, 2 years QA/regulatory experience in manufacturing (preferably in vitro diagnostics), and 4 years in relevant subsystems. Strong writing and MS Office skills are essential.

Qualifications

• BS/BA degree in chemistry, biology, or other scientific discipline or equivalent combination of education and work experience.
• 2 years’ experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics.
• 4 years of relevant work experience in assigned subsystem(s).
• Writing and Communication Skills (e.g. write technical reports, present data analysis).
• Experience with MS Office including excel and power point.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes including training, CAPA activities, equipment maintenance, product and process planning, quality audits, validation.
• Aid in implementing process improvements with respect to Quality Assurance processes.
• Maintain Quality metrics as required.
• Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations.
• Provide support to QA activities for regulatory compliance (e.g. Management Review support, regulatory audits).
• Assist in determining quality attributes and requirements.
• May provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Work with managers to coordinate training requirements for employees as required.
• Manage training program and organizational chart as required.
• Perform Quality System Training Requirements as needed.
• Review/approve supplier surveys and make recommendations as required.
• Assist with internal audits and agency audits.
• Manage Document Control as required.

Skills

Written & verbal communication

MS Office (Excel & PowerPoint)

Education

BS/BA in chemistry, biology, or related field

Tools

MS Office Suite

Job description

Abbott is seeking a Quality Assurance Specialist in the CMI ARDx Cardiometabolic and Informatics division in Taguig, Philippines. You will support site QA activities, work on document control, training, complaints, CAPA, supplier control, and regulatory compliance.

The role requires a BS/BA in a scientific field, 2 years QA/regulatory experience in manufacturing (preferably in vitro diagnostics), and 4 years in relevant subsystems. Strong writing and MS Office skills are essential.