Quality Assurance Specialist, Batch Records Raw Materials

ZipRecruiter; Auckland; On-site; NZD 99,000 - 121,000; Full time

Job summary

A leading global recruiter is seeking a Lead QA Representative in Auckland, New Zealand. The successful candidate will ensure timely and compliant release of raw materials and batch records, interact with various departments, and support cGMP inspections. This role requires a BS/BA in science and at least one year of relevant experience. The salary range is $58,300 - $70,700 annually.

Qualifications

• Minimum 1 year experience in Production or Quality Assurance.
• Ability to comply with gowning procedures for Manufacturing suites.

Responsibilities

• Review and approve quality records and batch records.
• Verify raw material documentation for compliance.
• Interact with departments for timely material release.
• Support cGMP compliance inspections.

Skills

Quality Assurance

Documentation Review

Regulatory Compliance

Inventory Management Systems

Education

BS/BA in science

Tools

SAP

LIMS

Job description

Overview

The position is responsible for serving as a lead QA representative for Raw Materials and Batch Records to ensure timely, compliant, and efficient release in support of manufacturing operations.

Key Responsibilities:

• Responsible for reviewing, approving, scanning, and binding quality records/batch records, and raw materials records.
• Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance with internal and regulatory requirements.
• Perform QA-related entries and reviews in inventory management systems (e.g., SAP or LIMS) related to raw material status changes (quarantine/release/reject).
• Ensure raw material handling and documentation activities are executed in compliance with applicable SOPs, cGMPs, and regulatory standards.
• Maintains spreadsheets for the review cycles of quality documents.
• Interact/communicate with various departments such as Manufacturing, Supply Chain and Quality Control to ensure timely and compliant material release and disposition activities.
• Coordinate corrections for quality documents internally and externally (e.g., client comments).
• Provide assistance to back room during cGMP compliance inspections, including retrieving quality documents/records and any other documentation requested during these inspections.
• Familiarize with Quality Assurance Operations.
• Complete MFG suite walk-throughs (as needed).
• Review HVAC reports (as needed).
• Support periodic audit readiness activities and participate in internal walkthroughs to ensure data integrity and documentation alignment across QA processes.
• Escalate material discrepancies and documentation issues promptly and follow up through closure to ensure timely resolution.
• Collaborate with QA Systems to support trending and KPI reporting related to raw material and batch record review cycle times.

Required Skills/Abilities:

• The job requires a BS/BA in science or equivalent work experience with 1 or more years' experience in either Production or Quality Assurance.
• Must be able to gown up and enter Manufacturing suites for walk-throughs and MRB labeling.

The annualized salary range for this role is $58,300.00 - $70,700.00.