Career Opportunities
Department: Quality Assurance
Job Title: Quality Assurance Specialist II
Description:
The Quality Assurance Specialist II will participate in all activities of the NeurogesX (NGX) Quality Assurance (QA) team to ensure cGMP compliance. The candidate will closely work with internal departments to communicate requirements and ensure efficient document flow. In particular, this position will provide
- Maintain stability program for API, Drug Product and placebo product to ensure compliance with protocol
- Perform compliance review of stability test data
- Ensure stability and batch analysis information is kept current with the Regulatory Affairs department for submission readiness
- Participate in first line review of executed batch records to support the release of API, Drug Product and Packaged (Finished) drug products
- Ensure complete assembly of lot release binder and documentation associated with the release of materials in accordance with project timelines
- Maintain tracking system and archival for CMO deviation and OOS
- Participate in shipment request
Job Requirements:
- B.S. in a scientific discipline is preferred, but not required
- Experience in the pharmaceutical, biotech, diagnostics, medical device or other technical or healthcare industry
- 2-6 years experience in Quality Assurance
- Knowledge of cGMP, GLP, GCP and ICH guidelines
- Good verbal communication skills
- Ability to work with some guidance and multitask
- Good attention to detail and accuracy
- Computer Skills: MSWord, MSExcel, MSPowerpoint, MSOutlook, Adobe Acrobat, MS Access desired