QA Specialist II (RE-12451398) South San Francisco, California

Salary: USD40 - USD50 per hour

QA Specialist II

A pharmaceutical company in South San Fransicso is looking for a QA Specialist II to join their team.

QA Specialist Duties:

  • Perform final review of Genentech manufactured cell banks and clinical drug substance, drug product and final drug product.
  • Compile Batch History Records for Product Manager review.
  • Scan documents into our GMP document management system. 
  • Review and Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
  • Provide Quality oversight to internal customers in the Manufacturing organization.
  • Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
  • Make independent decisions around complex issues in alignment with company policies.

  • Identify and implement process improvements, as necessary.

QA Specialist Requirements:

  • BS/BA degree in the life sciences plus 5-7 years experience. A minimum of at least 5 years experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience. Thorough knowledge of cGMPs (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies. 

  • Knowledge of cGMPs or equivalent regulations strongly preferred
  • Ability to interpret Quality standards for implementation
  • Ability to independently evaluate situations and propose potential solutions
  • Ability to interpret Quality standards for implementation
  • Aility to communicate clearly and professionally both in writing and verbally
  • Flexibility in problem solving and work hours to meet business objectives
  • Knowledge of SAP application and project management skills are highly desirable.

If you are interested in applying for this QA Specialist role, please respond to this job posting as soon as possible with an updated version of your resume.