Quality Assurance Specialist III CSV Hybrid

4 weeks ago


San Diego, California, United States Ajinomoto Bio-Pharma Services Full time
Quality Assurance Specialist III CSV Hybrid

Ajinomoto Bio-Pharma Services is seeking a Quality Assurance Specialist III CSV Hybrid to join our team. This role will be responsible for performing a wide variety of routine and semi-routine Quality Assurance (QA) support for CGMP operations, with a primary focus on QA oversight of Computer Systems Validation (CSV) activities.

The ideal candidate will have a Bachelor's degree in a scientific or engineering discipline and 5-7 years of applicable CGMP experience in a regulated industry. Knowledge of CGMP regulations 21CFR Part 11, 210, 211, 820 & EU guidelines, and specifically EudraLex Volume 4 Annex 11, good documentation practices, and data integrity is required.

The Quality Assurance Specialist III CSV Hybrid will participate in QA On the Floor (QAOTF) and compliance oversight activities related to Facility & Engineering (F&E) and Validation for reliability and business continuity to ensure that client specifications, production needs, and regulatory requirements are met.

The successful candidate will be responsible for reviewing and approving technical documentation, including validation documentation for electronic systems, and promoting a compliant and safe CGMP environment. They will also lead projects and train junior staff.

This is a hybrid schedule position located in San Diego, CA, and the anticipated salary range for candidates who will work in California is $103, $135,422.98.

Ajinomoto Bio-Pharma Services is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees.



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