Job Details

75% Onsite, shift: 8-5 standard hours, and potential evenings as the process requires

• Manage the development and implementation of clinical and commercial product specifications, in process control documents, and other specification related documents
• Facilitation of specification development meetings and the generation of detailed and communicate meeting minutes/action items to all attendees
• Other tasks include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner
• Own nonconformance records (NC), and lead or coordinate activities required to advance NCs to closure
• Implement and maintain a product quality data tracking system that facilitates meaningful analysis of release and in process test results (data mining)
• Assisting Product Quality leader function by facilitating team meetings and drafting/distributing meeting minutes, assisting in the management of product sample plans, as well as other assignments and projects as assigned

• Degree in life science, business or engineering
• Project management and/or industry experience
• Experience using computer software such as MS Office (i.e. Excel, Word, Project)
• GMP experience
• Single use technology, Cell Culture, Purification experience is nice to have
• Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
• Demonstrated ability to forge and maintain strong relationships within other functional areas
• Ability to recommend, judge, and make good decisions in complex situations
• Ability to tactfully and effectively negotiate and influence