Biopharmaceutical Quality Control Specialist

4 weeks ago

Sydney, New South Wales, Australia On Q Recruitment Full time
About the Role

The Quality Control Manager will play a pivotal role in shaping and leading the Quality Control function of our client.

This is a critical role in ensuring that all products meet stringent quality standards and that the company is inspection-ready as they scale.

Key Responsibilities

  • Manage the day-to-day operations of the Quality Control laboratory, including ensuring all QC equipment is validated and safely operated.
  • Lead, mentor, and manage the QC team, fostering a culture of accuracy, accountability, and continuous improvement.
  • Ensure analytical methods are adequately developed, validated, transferred, and maintained.
  • Develop, maintain, and communicate Lab Key Performance Metrics (KPIs).
  • Oversee the testing and release of raw materials, in-process samples, and final products, ensuring adherence to the highest quality standards.
  • Collaborate with cross-functional teams, including Manufacturing, QA, and Process Development, to optimise quality processes throughout the production lifecycle.
  • Ensure the timely identification, reporting, and resolution of deviations, OOS results, and quality-related issues.
  • Drive continuous improvement initiatives to enhance QC processes.

Requirements

  • Bachelor's or Master's degree in Biological Sciences, Biotechnology, or a related field.
  • At least 8 years of Quality Control experience, with experience working with biological products a must-have.
  • In-depth knowledge of GMP regulations and global standards (FDA, EMA, etc.).
  • Demonstrated experience in leading a QC team.
  • Strong problem-solving and analytical skills, with attention to detail.
  • Excellent communication skills, with the ability to collaborate across departments and drive QC excellence.
  • Ability to thrive in a fast-paced, growing environment and manage multiple priorities effectively.

Apply Now for a confidential conversation about the role.

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