Quality Assurance Specialist

1 week ago

Brisbane, Queensland, Australia beBeeQuality Full time $75,000 - $105,000
Job Title

Quality Assurance Specialist

About the Role

This role will support the Materials Management Team in maintaining quality and compliance systems. You'll work on continuous improvement projects, collaborate with global teams, and receive ongoing training to build a strong understanding of our quality systems.

Main Responsibilities
  • Daily execution of reject processes, including processing forms and visiting facilities.
  • Drafting of article code documents.
  • Executing change notification impact assessments; drafting and implementing change controls.
  • Assisting in supplier qualification, manufacturing, and service provider evaluation.
  • Raising and processing supplier complaints.
  • Assisting in regulatory and client audits from readiness activities through to engagement as an SME if required.
  • Maintaining effective working relationships with internal stakeholders from other teams and departments.
  • Participating in continuous improvement initiatives that realise cost savings and drive efficiency.
  • Updating standards operating procedures (SOPs) and other documents to meet current regulatory and corporate standards.
  • Ownership of quality records including deviations, out-of-specifications, CAPAs, audit findings, etc.
  • Participating in global projects and initiatives related to the Materials Management Team's remit, as required.
  • KPI reporting as needed.
Requirements

Tertiary education in a science or engineering-based field (e.g., biopharmaceuticals manufacture, biotechnology, process technology).

Previous experience in the pharmaceutical industry.

Good knowledge of cGMP.

Flexible and adaptable attitude.

Strong written, verbal, and interpersonal communication skills.

Collaborative skills with the ability to build rapport with internal and external stakeholders.

Key Skills
  • Continuous Improvement
  • Adaptability
  • Collaboration
  • Customer Focus and Integrity
  • Action Orientation
  • Relationship Management
  • Quality Mindedness

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