QC Method Transfer Specialist – NPI

AstraZeneca plc

Dublin

Hybrid

EUR 55,000 - 75,000

Full time

3 days ago
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Job summary

Are you ready to apply rigorous analytical science to accelerate the introduction of new therapies for people with rare and devastating diseases? As a QC Analyst within our Analytical New Product Introduction (NPI) team, you will bridge development and commercial QC by executing method transfers and validations that ensure robust, compliant testing from day one.

Your work will directly influence product release reliability and speed, safeguarding supply continuity for patients who cannot wait.

Qualifications

  • Biochemistry/Chemistry knowledge.
  • Investigation methodology and troubleshooting.
  • Attention to detail in following procedures.
  • Technical writing and report writing skills.
  • Ability to use AI tools to support technical writing with compliance awareness.
  • Ability to work with minimal supervision.

Responsibilities

  • Execute Analytical Method Transfer and Validation activities with accuracy and compliance.
  • Maintain cGMP standards and ensure data integrity.
  • Lead method troubleshooting and investigations to resolve anomalies.
  • Troubleshoot instrumentation and introduce appropriate technologies to improve robustness.
  • Document aberrant results, produce high-quality reports, contribute to risk assessments and change controls.
  • Maintain and share training to uplift team capability.
  • Collaborate with QC, Development and Manufacturing for tech transfer and steady-state testing.
  • Drive continuous improvements to reduce deviations and improve right-first-time outcomes.

Job description

Are you ready to apply rigorous analytical science to accelerate the introduction of new therapies for people with rare and devastating diseases? As a QC Analyst within our Analytical New Product Introduction (NPI) team, you will bridge development and commercial QC by executing method transfers and validations that ensure robust, compliant testing from day one.

Your work will directly influence product release reliability and speed, safeguarding supply continuity for patients who cannot wait.

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