Quality Laboratory Specialist

4 days ago


Ventura, California, United States AVITA Medical Americas, LLC Full time
Job Summary

AVITA Medical is a leader in regenerative medicine, and we are seeking a highly skilled Quality Laboratory Analyst to join our team. The successful candidate will be responsible for performing lot release testing for our AVITA family of products, ensuring compliance with established procedures and regulatory guidelines.

Key Responsibilities

  • Conduct routine and non-routine analysis of raw materials, in-process items, and finished products according to established procedures and cGLP guidelines.
  • Compile test records and review data to ensure accuracy and compliance.
  • Review test results to identify any quality anomalies and report them to the relevant stakeholders.
  • Perform OOS investigations according to written procedures and ensure timely resolution.
  • Coordinate and track projects, ensuring timely completion and compliance with regulatory requirements.
  • Validate and qualify equipment and processes to ensure accuracy and reliability.
  • Calibrate and verify equipment prior to use, ensuring compliance with regulatory requirements.
  • Ensure compliance with regulatory agencies and requirements, including FDA guidelines.

Requirements

  • 3-5 years of laboratory experience, with a focus on microbiology and FDA-regulated industries.
  • Bachelor's degree or equivalent in a scientific field, such as biology, chemistry, or microbiology.
  • Proficient in MS Office applications, including Excel and Word.
  • Strong work ethics, organizational skills, and ability to work independently and in a team setting.
  • Ability to work cross-functionally and communicate effectively with stakeholders.
  • Knowledge and understanding of analytical methodologies and instrumentation, as well as regulatory requirements.

What We Offer

AVITA Medical is an Equal Opportunity Employer, committed to creating an inclusive environment for all employees. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and regulatory compliance, we encourage you to apply for this exciting opportunity.



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