What are the responsibilities and job description for the Manager, Quality Assurance position at Neurona Therapeutics?
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
We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.
If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.
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
- 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
We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position.
If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at https://www.cisa.gov/be-cyber-smart/report-incident to learn how to report it.
