Quality Assurance Specialist

5 days ago

Ventura, California, United States Avita Medical Full time
Job Title: Quality Laboratory Specialist

AVITA Medical is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. Our FDA-approved RECELL System technology platform treats patients with thermal burn wounds and full-thickness skin defects and is used for re-pigmentation of stable depigmented vitiligo lesions by harnessing the regenerative properties of a patient's own skin to create Spray-On Skin cells.

Job Summary:

The primary job function of the Quality Laboratory Specialist is to perform lot release testing for the AVITA family of products. This role requires a strong understanding of analytical methodologies and instrumentation, as well as knowledge of Current Good Manufacturing Practices (cGMP), Current Good Laboratory Practices (cGLP), FDA guidelines, and other regulatory requirements.

Key Responsibilities:
  • Conduct routine and non-routine analysis of raw materials, in-process items, and finished product according to established procedures and cGLP guidelines.
  • Compile test records and review data.
  • Review test results to ensure compliance with standards and report any quality anomalies.
  • Perform OOS investigations according to written procedures.
  • Project tracking and coordination.
  • Validation and qualification activities.
  • Calibration and calibration verification of equipment prior to use.
  • Compliance with regulatory agencies and requirements.
Requirements:
  • 3-5 years of laboratory experience required.
  • Microbiology laboratory experience a plus.
  • FDA regulated industry (food, pharmaceutical, or medical device) experience a plus.
  • Bachelor's degree or equivalent in a scientific field.
  • Proficient in MS Office applications, such as Excel and Word.
  • Strong work ethics and organizational skills.
  • Ability to work independently and in a team setting.
  • Ability to work cross-functionally.
  • Knowledge and understanding of analytical methodologies and instrumentation.
  • Understanding of cGMP, cGLP, FDA guidelines, and other regulatory requirements.

AVITA Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business needs.

Your Physical Work Environment Will Require: The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, and hear, stand, walk, and/or balance, use hands and fingers to type, handle, feel, grasp, push, and pull. Hand-eye coordination is necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus. The individual is frequently required to reach with hands and arms, and repetitive motion. The individual is occasionally required to stoop, kneel, or crouch. The individual may occasionally lift and/or move up to 25 pounds.

AVITA Medical is an E-Verify participant.

AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner. AVITA Medical is committed to protecting the security of its information and information systems. As such, each role within AVITA Medical must demonstrate the same commitment to information security.

Salary: $38.00 Hourly

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