Quality Assurance Specialist

4 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $90,000 - $120,000

We are looking for a highly skilled Quality Assurance Specialist to join our team and support the establishment of in-house quality control capabilities.

This role is pivotal in ensuring the reliability and consistency of our testing practices. You will collaborate with cross-functional teams to build our quality assurance framework from the ground up.

Key Responsibilities:
  • Setting up and operationalising the new quality laboratory.
  • Transferring, validating, and qualifying analytical methods for internal use.
  • Implementing robust procedures for method documentation and compliance.
  • Performing quality testing of incoming raw materials to ensure conformance with specifications.
  • Conducting in-process quality assessments to support manufacturing and scale-up activities.
  • Troubleshooting and refining quality workflows to ensure data integrity and efficiency.
  • Executing and documenting final product testing to support batch release.
  • Investigating any out-of-specification results or quality deviations in coordination with QA.
  • Maintaining high standards of GMP documentation and record-keeping.
  • Supporting the development of Standard Operating Procedures (SOPs), forms, and test records.

Requirements include:

  • Prior experience in a Quality Control role within a pharmaceutical, biotechnology, or related laboratory environment.
  • Strong knowledge of laboratory instrumentation and analytical techniques relevant to raw material and finished product testing.
  • Experience with method transfers and laboratory setup is highly desirable.
  • Understanding of GMP/GLP and regulatory expectations related to quality assurance.
  • Excellent attention to detail, organisation, and problem-solving skills.
  • Ability to work autonomously and adapt to a fast-moving, start-up style environment.

Benefits:

  • Opportunity to work in a dynamic and rapidly evolving laboratory environment.
  • Chance to contribute to the development of in-house quality control capabilities.
  • Collaborative and supportive team environment.

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