Quality Assurance Officer

BJP Laboratories; Gold Coast City; On-site; AUD 90,000 - 120,000; Full time

Job summary

BJP Laboratories on the Gold Coast is seeking QA/QMS professionals to manage the Quality Management System activities across manufacturing, GMP-compliant processes and regulatory alignment. You will investigate deviations, customer complaints, NCRs, and CAPAs, perform root cause analysis, and support continuous improvement while ensuring compliance with ARTG/TGA requirements and GMP standards.

You will draft, review, and maintain GMP documentation, participate in internal audits and regulatory

Qualifications

• Experience with QMS in regulated manufacturing industries.
• Familiarity with CAPAs, NCRs, deviations and change controls.
• Ability to perform root cause analysis and trend data.
• Knowledge of ARTG, TGA, GMP, and batch records.

Responsibilities

• Manage QMS activities including customer complaints, deviations, NCRs, CAPAs, and audits.
• Draft, review, and maintain QMS documentation and product specifications.
• Support internal audits and regulatory inspections and drive continual improvement.

Job description

Manage Quality Management System (QMS) activities including customer complaints, deviations, CAPAs, non-conformances (NCRs), change controls, and internal audits. Applicants must have previous experience working with QMS processes within the Complementary Medicines, Pharmaceutical, Food, or other regulated manufacturing industries.

Investigate quality events arising from Quality Management System (QMS) processes, including deviations, customer complaints, non-conformances (NCRs), and audit findings, to identify root causes and implement effective corrective and preventive actions (CAPAs).

Perform trend analysis of customer complaints and other quality events to identify recurring issues, assess risks, and implement appropriate CAPAs to drive continuous improvement.

Monitor and coordinate the timely closure of Quality Management System (QMS) events, ensuring actions are completed effectively and within required timeframes.

Draft, review, and maintain raw material specifications, finished product specifications, and "free from" statements in line with TGA and regulatory requirements.

Conduct supplier and vendor assurance activities for raw materials and packaging components.

Review and approve product labels to ensure compliance with ARTG listings, regulatory requirements, and internal procedures.

Create, review, and maintain Bills of Materials (BOMs) within company software systems.

Perform and verify potency calculations for active ingredients and raw materials.

Conduct in-process quality checks during manufacturing and packaging operations, including granulation, compression, coating, encapsulation, powder and liquid manufacturing, blister packing, bottle packing, and pouch filling.

Draft, review, and maintain Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) in accordance with GMP, product specifications, and TGA requirements.

Prepare and review Product Quality Reviews (PQRs) and support ongoing product lifecycle management.

Support the QA Manager in maintaining and continuously improving quality systems, SOPs, GMP compliance, and quality culture across the business.

Participate in internal audits, regulatory inspections, and quality improvement initiatives as required.