QA Specialist II

South San Francisco, California 94080 | Contract

Post Date: 02/27/2018 Job ID: 3933 Industry: Quality

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They  are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • Perform detailed and final review of manufacturing batch records for the Company manufactured cell banks, large molecule drug substance and drug product, and large and small molecule finished goods for IMP/clinic use
  • Collect and compile Batch History Records for Product Manager review
  • Assign batch record review and maintain scheduling database
  • Scan and archive documents into a GMP document management system
  • Troubleshoot and initiate the resolution of Quality issues by fostering effective cross-functional partnerships
  • Make independent decisions around issues in alignment with Company policies
  • Identify and implement process improvements, as necessary

 

Skills:

  • Thorough knowledge of cGMPs, and regulations applicable to U.S. and international Regulatory agencies
  • Must be able to apply cGMP concepts and requirements in order to evaluate product release and use sound judgment and decision-making skills
  • Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential
  • Familiarity with computer systems and knowledge of EDMS, LIMS, SAP and Trackwise applications is highly desirable

 

Education:

  • B.A. or B.S. degree (preferably in Life Science) plus 2-4 years of work experience
  • A minimum of at least 2 years of 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
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