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QA Associate
Bristol Myers Squibb
- Bothell, Washington, United States
- Bothell, Washington, United States
À propos
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 hosting of regulatory and customer audits. Performs general and/or more complex manufacturing formulation batch production record reviews and approvals 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. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data. Provides site-wide support during daily walkthroughs of GMP areas. Qualifications
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 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 quality assurance function Knowledge of pharmaceutical or biotech product manufacturing Knowledge of US and EU cGMP regulations and guidance Knowledge of SAP or equivalent ERP System; BMRAM, MES, Veeva or TrackWise systems are a plus Role may entail use of disinfection agents (such as IPA or Sporklenz), gowning/PPE requirements to enter clean room spaces and handling of blood-based drug products Details
100% onsite Work Schedule: Wednesday – Saturday, 6:00 AM – 4:30 PM PST (Shift: 4 x 10 h) Contract assignment with ASK Staffing to provide services to Bristol Myers Squibb Compensation: starting range $31.00 – $34.22 per hour. Final compensation determined by employer of record based on assignment characteristics, experience, skills, and location
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Compétences linguistiques
- English
Avis aux utilisateurs
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