Experienced Quality Assurance Specialist Wanted

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time $120,000 - $150,000
Job Title: Quality Assurance Specialist

We are seeking a seasoned Quality Assurance professional to support our expanding laboratory operations.

Main Responsibilities:

  • Lab Setup & Method Transfer: Assist with the setup and operationalisation of the new quality control laboratory, including method transfers and laboratory setup.
  • Method Validation & Qualification: Lead or support the validation and qualification of analytical methods for internal use.
  • Raw Material & In-Process Testing: Perform quality testing of incoming raw materials to ensure conformance with specifications and conduct in-process quality assessments to support manufacturing and scale-up activities.
  • Troubleshooting & Efficiency: Troubleshoot and refine quality control workflows to ensure data integrity and efficiency.
  • Finished Product Testing: Execute and document final product testing to support batch release and investigate any out-of-specification results or quality deviations in coordination with QA.
  • Documentation & Compliance: Maintain high standards of good manufacturing practice (GMP) documentation and record-keeping and assist with audits, internal inspections, and continuous improvement initiatives.

Requirements:

  • Prior hands-on experience in a quality assurance 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.

This is a pivotal role for someone who is passionate about quality, thrives in a fast-paced environment, and is ready to hit the ground running as we establish in-house quality control capabilities.

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