Job Description :
Pay Range $32hr - $35hr
Skills :
- Documentation Review experience.
- Scientific Degree.
- Experience working in a GMP environment.
- Okay with candidates out of college who have a biology or similar degree who are looking for GMP experience.
- 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.
- Performs general and 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.
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.
Requirements :
- Lab w / blood & animal.
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