Quality Control Scientist II

📋 Description

• Represent the QC function on cross functional program teams.
• Collaborate with analytical leads to achieve release and stability program deliverables.
• Author quality documents and IND/IMPD sections to enable regulatory submissions and clinical supply.
• Evaluate and trend stability data using JMP or other statistical software to support retest dating
• Prepare and review/verify quality control documents, including certificates of analysis, reference
• Initiate and review change records in collaboration with Technical and Quality SMEs and

🎯 Requirements

• BS or equivalent education with typically 7 or more years of experience or MS or equivalent
• Must have a minimum of two years hands-on experience:
• Lab experience with methods commonly employed for release and stability testing of antibody
• Evaluating and trending of GMP stability data for drug substance and drug product shelf-life
• Use of data analysis tools (e.g. JMP) and LIMS systems.
• Document management in the biopharmaceutical industry, including GxP electronic document management

🎁 Benefits