QC/QA Associate

QC/QA Associate 

QC/QA Associate
QC/QA Associates are responsible for supporting quality systems to advance the development and manufacture of drug candidates, including data and document review and approval, support of GMP manufacturing, and assistance with internal and external auditing.

Responsibilities include, but are not limited to the following:
  • Review and approve release and stability data, certificates of analysis, development and validation reports, analytical testing protocols, and stability chamber validations
  • Maintain Quality Assurance logbooks for document change control, instrument calibration schedule, stability pull schedule, test method and technical reports, and certificates of analysis
  • Perform internal audits of the analytical laboratories and Quality Assurance systems as well as in-phase audits of GLP studies
  • Support GMP manufacturing activities including release of GMP materials, performance of line clearances in a Class 100,000 environment, maintenance of clinical trial material inventory logs
  • Supportive role in hosting client and regulatory audits
Requirements
  • Candidate will have a BS/BA science degree (Chemistry or Biochemistry preferred).
  • Candidate will have 1 to 2 years of analytical chemistry/HPLC experience 
  • Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude. This position requires a high level of interaction with multiple departments, as well as clients.

  • Location: San Diego
  • Type: Contract to Perm
  • Job ID: BR710171114