Description:

• Primary responsible for quality oversight of GMP documents related to site startup activities.
• Some of these activities include reviewing and approving GMP documents, communicating with site SMEs for document adequacy, communicating action progress to Manager level.
• knowledge of process and facility equipment, ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry; written and spoken fluency required in English.   
• High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree 
• Experience reviewing and approving GMP documents from a Quality role, experience working in a fast paced environment, ability to interpret and apply Good Manufacturing Practices (GMP)
• Document management experience
• Manage GMP documents for review and approval as part of the start-up activities, communicate updates to Manager level, and triage documents for adequacy