Technical Manager III

South San Francisco, California 94080 | Contract

Post Date: 03/29/2018 Job ID: 4053 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:
  • Facilitate and document resolution of issues identified with quality system data content. 
  • Collaborate and communicate proactively with local/global sites as needed to ensure report accuracy. 
  • Assist in modifying format and content of quality reports and achieve compliance with company procedures and applicable regulations. 
  • Provide support to team members to process stakeholder' s feedback on quality reports. 
  • Collect, analyze and report metrics as needed. 
  • Support department to meet corporate goals and department objectives.

 

 

Skills:  

  • Trackwise, Excel, PowerPoint and Word experience required. 
  • Sound knowledge of Quality Systems is essential and a good understanding of cGMP regulations is required. 
  • Strong time management skills and ability to prioritize own work. 
  • Experience reviewing documentation (quality checks). 
  • Excellent written and verbal communication skills. 
  • Strong interpersonal, influence, initiative, task management and negotiation skills. 
  • Ability to manage multiple, changing priorities in a fast-paced environment is essential. 
  • Strong attention to detail is required.

 

Education:

  • 4-6 years pharmaceutical experience is required. 
  • At least four years direct experience in quality assurance for pharmaceutical operations is strongly preferred. 
  • BS or BA in a relevant scientific discipline or equivalent and demonstrated working knowledge of quality assurance and manufacturing principles.
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