Senior Quality Assurance Specialist

7 days ago


Colònia de Sant Jordi, Baleares, United States Immucor Full time
Improve Quality and Reliability

We are seeking a highly skilled Quality Control Technologist III to join our team at Immucor, a global leader in transfusion and transplantation diagnostics. This critical role will oversee the stability of our medical devices and pharmaceuticals, ensuring they meet the highest standards of quality and reliability.

About the Role

This position is responsible for leading QC stability projects, performing Incoming, In-process, final release, and stability testing in the Quality Control Laboratory. The ideal candidate will have a strong background in biology or chemistry and experience working in a GMP quality laboratory.

Key Responsibilities

  • Develop and implement stability protocols and reports
  • Perform product testing and trending stability data
  • Lead QC projects and ensure compliance with regulations
  • Provide guidance and training to QC staff
  • Maintain accurate records and reports

Requirements

  • Bachelor's degree in biology or chemistry or related field
  • Four (4) or more years experience in a medical device or pharmaceutical GMP quality laboratory
  • Experience working under 21 CFR Part 210/211 and/or 820 regulations required
  • Knowledge of ISO 13485 desired

Salary and Benefits

The estimated salary for this position is $80,000 - $110,000 per year, depending on experience. We offer a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan and tuition reimbursement.



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