Description
This pharmaceutical company in Palo Alto is seeking a QA specialist to perform key quality assurance tasks, focusing primarily on GxP, other than GMP except when necessary.Responsibilities
The QA specialist will support the clinical operations group as well as the drug safety department. Responsibilities include:
- Perform GCP and GLP audits, internal audits of drug safety, clinical operations and regulatory affairs
- Support functional groups in development of standard operating procedures for all QxP activities
- Support the product complaints department and review validation protocols and reports, when required
- Ensure the timely completion of all quality assurance related activities by working closely with the Quality Systems group and the functional groups
- Support the commercial GMP operational quality group
Desired Skills & Experience
- Bachelor's degree in chemistry, biology or a related discipline
- Significant experience (3-5 years) working in pharmaceutical/biologics
- Experience in auditing: including internal and external third party vendor and CRO's.
- Strong work ethic with a high level of organization
- Up to 25% travel may be required
To find out more about Real please visit www.realstaffing.com