Description:

Exact Shift - remote role, 40hrs a week.

Job Details: 

• Manage the development and implementation of clinical and commercial raw material specifications and other specification related documents. 
• Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers). 
• Interface cross-functionally within (with Process Development, Quality, Supply Chain and other GMP functions) and externally with raw material suppliers. 
• Draft specifications based on raw material attributes, where they are used in the process and how they should be controlled. 
• Facilitate specification development meetings and generate meeting minutes/action items to partners to ensure completion of tasks. 
• Other responsibilities 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. 

Skills: 
Degree in Life Science or Engineering (Biochemistry, Analytical Chemistry, Bio-Manufacturing, Process development, Chemistry, Biology, Engineering); preference will be given to advance degree holders and/or those who have industry and project management experience.

Basic Qualifications    
Doctorate degree or Master degree and 3 years of experience or Bachelor degree and 5 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience

Top 3 Must Have Skill Sets:    

• Project management experience
• Experience in GMP controlled documents management
• Knowledge of ERP Systems (SAP)

Pay Rate  between $41 - $47hr on W2 based on experience.
 
"This posting is for Contingent Worker, not an FTE"