Quality Assurance Specialist - CAPA & Compliance

Abbott; Taguig; On-site; PHP 420,000 - 640,000; Full time

Job summary

Abbott Rapid Diagnostics seeks a Quality Assurance Specialist to support the CMI Business Unit, focusing on document control, training, complaints, nonconformances, CAPA and supplier control. You will implement and maintain the Quality System and assist with regulatory compliance activities.

Responsibilities include maintaining quality metrics, participating in CAPA, audits, training, and change control, and coordinating with management to ensure accurate documentation and timely training across

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.
• Must be detail-orientated, self-motivated and available for flexible scheduling.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes including CAPA, audits, training, and equipment maintenance.
• 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.
• Assist in determining quality attributes and requirements and provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Work with managers to coordinate training requirements for employees.
• Manage training program and organizational chart as required.

Skills

Detail-oriented

Writing & communication

Flexibility

Self-motivated

Team collaboration

Education

BS/BA in chemistry or biology or related scientific discipline

Tools

MS Office

Excel

PowerPoint

Job description

Abbott Rapid Diagnostics seeks a Quality Assurance Specialist to support the CMI Business Unit, focusing on document control, training, complaints, nonconformances, CAPA and supplier control. You will implement and maintain the Quality System and assist with regulatory compliance activities.

Responsibilities include maintaining quality metrics, participating in CAPA, audits, training, and change control, and coordinating with management to ensure accurate documentation and timely training across