Quality Assurance Associate

Healthcare Professionals Group; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

Healthcare Professionals Group is seeking a hands-on Quality Assurance professional to support day-to-day QC activities across pharmaceutical storage and distribution operations.

You will contribute to product release, temperature excursions investigations, customer complaints and quality investigations, while supporting audits and CAPAs and driving continuous improvement with internal teams and external partners.

Qualifications

• Must have tertiary technical qualification or equivalent practical experience.
• Demonstrated experience in the pharmaceutical industry.
• Experience with GDP and GMP quality management systems.
• Ability to build cross-functional relationships.
• Able to work independently and collaboratively with flexible priorities.

Responsibilities

• Review and approve product release for distribution, ensuring quality standards.
• Investigate temperature excursions and assess impact on product quality.
• Manage customer complaints and returned product assessments with investigations.
• Prepare quality reports and performance metrics highlighting trends and risks.
• Support quality risk assessments, deviations, root cause analysis and CAPAs.
• Maintain training records and support GDP, GMP training.
• Participate in internal/external audits and follow up on findings.
• Review approvals and coordinate reapprovals for customers/vendors.
• Support change control, recall management and other quality improvements.

Skills

Technical discipline education

Pharmaceutical industry experience

GDP/GMP quality systems experience

Relationship building across functions

Independent and collaborative work

Education

Tertiary qualification in technical discipline

Job description

• Broad, hands-on quality assurance role within the pharmaceutical industry.
• Exposure to product release, investigations, audits and continuous improvement.
• Contribute to quality improvement projects and global initiatives.

Benefits

• Broad, hands-on quality assurance role within the pharmaceutical industry.
• Exposure to product release, investigations, audits and continuous improvement.
• Contribute to quality improvement projects and global initiatives.

About the company

Our client is a pharmaceutical organisation bringing together specialist expertise and industry partnerships to support the supply of medicines. The business takes a collaborative approach, with teams working across functions to support its customers and partners.

About the opportunity

Reporting to the Quality Manager, you will support day-to-day quality assurance activities across pharmaceutical storage and distribution operations. This is a varied role that combines hands-on operational quality with opportunities to contribute to wider business improvements. You will work across product release, temperature excursions, complaints and quality investigations, while building relationships with internal teams, manufacturers and logistics providers. This opportunity would suit someone who enjoys solving problems, taking ownership of their work and collaborating across different areas of a business.

Duties

• Review and approve product release for distribution, ensuring quality requirements are met and decisions are appropriately documented.
• Investigate temperature excursions and assess their impact on product quality.
• Manage customer complaints and returned product assessments, coordinating investigations and appropriate follow-up actions.
• Prepare quality reports and performance metrics, highlighting trends, risks and improvement opportunities.
• Support quality risk assessments, deviation investigations, root cause analysis and corrective and preventive actions (CAPAs).
• Maintain training records and support the delivery of GDP, GMP and procedural training.
• Participate in internal and external audits, support inspections and follow up on findings.
• Review customer and vendor approvals, maintain records and coordinate periodic reapprovals.
• Support change control, recall management and wider quality improvement initiatives.

Skills and Experience

• Tertiary qualifications in a technical discipline, or relevant practical experience.
• Demonstrated experience within the pharmaceutical industry.
• Experience working within Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) quality management systems.
• Ability to build effective relationships across functions.
• Comfortable working independently and collaboratively, with the ability to adapt to changing priorities.

Culture

Join a quality-focused environment where collaboration and continuous improvement are shared priorities.