Batch Release Auditor

Thornton Tomasetti; Pokeno; On-site; NZD 70,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Wellbeing support

Competitive rewards

Job summary

Abbott in New Zealand (Pokeno Plant) is seeking a Batch Record Auditor to verify batch records for compliance with policies, procedures and regulatory requirements. The role ensures documentation completeness and supports timely product release.

The position requires a science/technical degree and at least 2 years in QA, internal auditing, or related quality compliance roles. Strong communication and organizational skills are essential.

Qualifications

• Bachelor’s degree in scientific or technical discipline or equivalent experience.

Responsibilities

• Maintain and improve batch release system for compliance and product quality.
• Conduct batch record audits for completeness and regulatory adherence.
• Follow up issues to enable accurate batch release decisions.
• Coordinate corrective action plans and verification activities from quality events.
• Ensure records and deviations are documented for reporting and metrics.
• Generate routine reports to support batch release and compliance monitoring.
• Perform data collection and document review to support quality and operational effectiveness.

Skills

Quality Assurance

Auditing

Problem-solving

Communication

Education

Bachelor's degree in science/technical

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.

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

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: ANSC Nutrition Supply Chain

LOCATION: New Zealand > Waikato: Pokeno Plant

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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