Batch Release Auditor: Quality & Compliance Expert

Abbott; Auckland; On-site; NZD 80,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Job summary

Abbott is seeking a Batch Release Auditor in Auckland to audit batch records, ensure compliance with policies and regulatory requirements, and maintain accurate documentation for timely product release.

The role involves improving the batch release system, coordinating CAPAs, and generating reports to support quality and compliance metrics. A science/technical degree and 2+ years in quality assurance are expected.

Qualifications

• Bachelor’s degree in a scientific or technical field or equivalent regulated work experience.
• Strong judgment, problem-solving and decision-making abilities.
• Clear written and verbal communication with stakeholders.
• Well-organized with good technical aptitude and regulatory knowledge.

Responsibilities

• Maintain and improve the batch release system to ensure compliance and timely product disposition.
• Audit batch records for completeness, accuracy, and adherence to Abbott policies and regulations.
• Follow up on issues to enable informed batch release decisions.
• Coordinate corrective action plans, sampling, verification, and disposition assessments.
• Document deviations and non-conformances for reporting and metrics.
• Use batch release systems to manage material and status transactions.
• Hold or isolate affected materials when required and ensure proper rework or disposal.
• Generate routine reports to support compliance monitoring and business needs.
• Provide compliance support through data collection and record verification.

Skills

Judgment

Problem-solving

Decision-making

Effective communication

Organized

Tech-savvy

Regulatory knowledge

Education

Bachelor’s degree in science/technical discipline

Job description

Abbott is seeking a Batch Release Auditor in Auckland to audit batch records, ensure compliance with policies and regulatory requirements, and maintain accurate documentation for timely product release.

The role involves improving the batch release system, coordinating CAPAs, and generating reports to support quality and compliance metrics. A science/technical degree and 2+ years in quality assurance are expected.