Batch Release Auditor

About Abbott

Abbott is a globally recognized healthcare leader committed to pioneering scientific advancements that enhance human health. Their nutrition division designs science-backed nutritional solutions catering to all life stages, including infants, children, and adults. Trusted global brands under Abbott's nutrition portfolio include Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna®, which support millions in achieving optimal health.

Working at Abbott

Abbott offers meaningful work, opportunities for professional growth, and a supportive environment that values authenticity and work-life balance. Employees benefit from career growth within an international framework, comprehensive health and wellbeing programs, substantial medical insurance, and competitive rewards that acknowledge contributions. Abbott is recognized worldwide as a top workplace and ranks among the most respected companies by Fortune.

Role Overview - Batch Release Auditor

The Batch Release Auditor will review and validate batch records to ensure they align with corporate policies, procedures, and regulatory standards. This role is critical for guaranteeing that all essential documentation is complete and accessible within batch records, maintaining accurate databases, and facilitating prompt retrieval of historical batch information.

Key Responsibilities

• Continuously enhance and uphold the batch release system to maintain compliance, ensure product quality, and support prompt product disposition.
• Perform detailed audits of batch records to confirm completeness, precision, and adherence to Abbott policies, procedural requirements, deviations, and regulatory standards.
• Address identified discrepancies to secure definitive disposition details for informed batch release decisions.
• Manage and document corrective action plans, sampling, verification tasks, effectiveness assessments, and disposition evaluations following quality and compliance incidents.
• Accurately document and record batch records, deviations, non-conformances, and related compliance events to facilitate reporting, trend analysis, and performance metrics.
• Operate batch release systems to track material and batch statuses, guaranteeing correct product disposition and release information.
• Ensure proper handling of materials/products, including holds or isolation when necessary; verify and document rework, sorting, disposal, or other disposition activities in compliance with site protocols.
• Generate standard reports and extract data supporting batch release processes, compliance monitoring, reporting, and business needs.
• Carry out routine compliance support including document review, data gathering, record verification, and administrative duties to promote product quality and operational efficiency.

Candidate Requirements

• Possess a Bachelor’s degree in a scientific or technical field, or an equivalent combination of education and relevant work experience in regulated environments.
• Bring at least 2 years of experience in Quality Assurance, Internal Auditing, Quality Compliance management, or similar roles.
• Demonstrate sound judgement, strong problem-solving, and decision-making capabilities.
• Exhibit effective verbal and written communication skills coupled with strong interpersonal and consulting abilities.
• Be well-organized and proficient in technology.
• Have an excellent understanding of the technical and regulatory landscape relevant to the position.

Work Location

This full-time position is located in Pokeno, Waikato, New Zealand. Abbott supports diverse career development opportunities and champions equal employment opportunity, valuing employee diversity.