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QA Associate
3 months ago
Location: Bothell, WA - 98021
Duration: 12 Months
100% onsite
Top 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.
Summary :
- 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.
Roles and Responsibilities:
- 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.
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
Additional Job Requirements: Lab w/ blood & animal