Neurona Therapeutics
Manager, Quality Assurance
Neurona Therapeutics, South San Francisco, California, us, 94083
Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of cell-based therapies for neurological diseases. We are seeking a self-motivated and Quality Assurance Manager.
Responsibilities include:
Track, analyze, and report QA metrics Review and approval of facility validation protocols, data, and reports Review and approval of controlled documents such as protocols, master batch records, specifications, and standard operation procedures Review and approval of product and raw material specifications Independent review of executed batch records, and raw material release data Performing internal and external audits Review and approval of deviation and investigation documentation Review and approval of GMP shipments Management of temperature excursions Effectively work with other departments to streamline and improve Neurona's QMS Conduct personnel GMP training Work with Regulatory and Clinical Operations supporting Neurona's clinical trials Other additional QA tasks as directed by QA Management Required Qualifications:
BS science degree, preferably in Chemistry, Biochemistry or Biology Minimum of 5 years of applicable GMP industry experience in QA, QC or Manufacturing Strong foundation in the Clinical Supply Process or equivalent pharma/healthcare supply chain process Strong experience with managing quality systems records, conducting investigations/deviations In-dept knowledge of cGMP
Interested in joining a cutting-edge team dedicated to advancing cell-based therapies for neurological diseases? Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
Responsibilities include:
Track, analyze, and report QA metrics Review and approval of facility validation protocols, data, and reports Review and approval of controlled documents such as protocols, master batch records, specifications, and standard operation procedures Review and approval of product and raw material specifications Independent review of executed batch records, and raw material release data Performing internal and external audits Review and approval of deviation and investigation documentation Review and approval of GMP shipments Management of temperature excursions Effectively work with other departments to streamline and improve Neurona's QMS Conduct personnel GMP training Work with Regulatory and Clinical Operations supporting Neurona's clinical trials Other additional QA tasks as directed by QA Management Required Qualifications:
BS science degree, preferably in Chemistry, Biochemistry or Biology Minimum of 5 years of applicable GMP industry experience in QA, QC or Manufacturing Strong foundation in the Clinical Supply Process or equivalent pharma/healthcare supply chain process Strong experience with managing quality systems records, conducting investigations/deviations In-dept knowledge of cGMP
Interested in joining a cutting-edge team dedicated to advancing cell-based therapies for neurological diseases? Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.