Description :

• Maintains shop floor quality presence, disposition in-process materials and finished product, investigates and resolves GDP errors, and performs batch record reviews.
• Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines.
• May assist in preparing for a hosting of regulatory and customer audits.
• Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
• Inspects and releases intermediates or packaged drug product per specifications.
• Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
• Drafts and reviews specifications and SOPs.
• Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
• May provide guidance to less experienced staff.
• Provides sitewide support during daily walkthroughs of GMP areas.

• B.S., in Biology, Chemistry or related discipline, or its equivalent is preferred.
• Documentation Review experience
• Experience working in a GMP environment
• Open to candidates out of college who have a biology or similar degree who are looking for GMP experience.
• 2+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
• Knowledge of biotech product manufacturing.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of Oracle, BMRAM, MES, Veeva Infinity are a plus