Batch Release Auditor

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 a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands, including Similac®, PediaSure®, Pedialyte®, Ensure® and Glucerna®, to help get the nutrients they need to live their healthiest life.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.


• Benefits that support you and your family to stay healthy, financially secure, and supported throughout life's journey, including comprehensive medical insurance coverage, wellbeing support, and competitive rewards that recognize your contributions.


• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

The Opportunity

As the Batch Release Auditor, this role audits the accuracy of batch records to be compliant with policies, procedures, and regulatory requirements. This position ensures all necessary documents are included within the batch record, maintains databases and batch record files so that retrieval for historical data is accurate and timely.

What You’ll Do

• Maintain and continuously improve the batch release system to ensure compliance, product quality, and timely disposition of finished products.


• Conduct batch record audits to verify completeness, accuracy, and compliance with Abbott policies, procedures, deviation requirements, and applicable regulatory requirements.


• Follow up on all identified issues to ensure appropriate disposition information is obtained, enabling accurate and informed batch release decisions.


• Coordinate and document corrective action plans, sampling and verification activities, effectiveness reviews, and disposition assessments arising from quality and compliance events to support product release decisions.


• Ensure batch records, deviations, non-conformances, and other relevant compliance events are accurately documented and captured for reporting, trending, and performance metrics.


• Utilise batch release systems to manage material and batch status transactions, ensuring accurate product disposition and release status.


• Ensure affected materials and products are appropriately placed on hold or isolated when required, and verify that rework, sorting, disposal, or other disposition activities are completed, documented, and closed out in accordance with site procedures.


• Generate routine reports and retrieve data to support batch release activities, compliance monitoring, performance reporting, and business requirements.


• Perform routine compliance support activities, including document review, data collection, record verification, and administrative tasks to support product quality, compliance, and operational effectiveness.

Requirements

• Bachelor’s degree in scientific or technical discipline OR an equivalent combination of education and work experience in a relevant regulated environment.


• Minimum 2 years Quality Assurance, Internal Auditing, Quality Compliance management or related experience.


• Demonstrates strong judgment, problem-solving, and decision-making skills.


• Communicates effectively (written and verbal) with strong interpersonal and consulting ability.


• Well-organized and tech-savvy.


• Excellent technical and regulatory local knowledge as it relates to the role.

Location:

This position is based in Richard Pearse Drive, Auckland.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.