Batch Release Auditor

Abbott; Pokeno; On-site; NZD 65,000 - 86,000; Full time

Job summary

Abbott in New Zealand is seeking a Batch Record Auditor to ensure batch records meet policies, procedures and regulatory requirements. You will maintain databases and ensure timely retrieval of historical data.

Based in Pokeno, Waikato, the role involves auditing batch records, coordinating corrective actions, generating reports and supporting product releases with strong attention to quality and compliance.

Qualifications

• Bachelor’s degree in a scientific or technical discipline or equivalent regulatory environment experience
• Strong judgment, problem-solving and decision-making skills
• Excellent written and verbal communication and interpersonal abilities
• Well-organized and tech-savvy with good regulatory knowledge

Responsibilities

• 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.

Skills

Quality Assurance

Auditing

Regulatory knowledge

Analytical thinking

Communication

Organization

Tech-savvy

Education

Bachelor’s degree in scientific or 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 Record 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 Pokeno, Waikato.

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.

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