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| Job #03111 |
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| About our client |
| Our client is a publicly traded biotechnology company headquartered in Los Angeles that focuses on the development and commercialization of various oncology therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. |
| Position |
Location |
| Quality Assurance Auditor |
Los Angeles, California |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Contribute to management of the company's overall quality and compliance by performing internal and external audits related, primarily, to GCP 2) Assist with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) activities (as required) 3) Assist in internal GCP audits to ensure compliance with company policies and procedures 4) Oversee Investigator sites, vendor facilities, study documentation as well as company systems and processes
5) Prepare, conduct, report and follow-up on audits of local and international
clinical studies, ensuring compliance with GCP, applicable regulations and the
company's quality standards 6) Assist Senior Manager QA in the information management of audits compliance of new and on-going programs
7) Respond effectively to a changing regulatory environment and assist in
advising functional departments on potential GXP impacts, ensuring compliance
with new and on-going programs 8) Assist in information flow between QA and functional departments |
| Requirements |
1) BA/BS in Science from an accredited college or university 2) Minimum 2 – 4 years of pharmaceutical auditing experience 3) Experience in GCP 4) Knowledge of GLP/GMP computer systems is a plus 5) Excellent communication skills (oral and written) 6) Strong organizational and time-management skills that are adaptable to a changing environment 7) Willingness to travel both nationally and internationally (up to 50%) |

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