Work Schedule: Wednesday - Saturday, 6AM - 4:30PM PST

Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; 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.

1. 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.
2. Inspects and releases intermediates or packaged drug product per specifications.
3. Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
4. Drafts and reviews specifications and SOPs.
5. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
6. May provide guidance to less experienced staff.
7. Provides sitewide support during daily walkthroughs of GMP areas.

Requirements:

• B.S., in Biology, Chemistry or related discipline, or its equivalent is preferred.
• 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