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Quality Assurance Specialist
2 months ago
Job ID: -
Location: Bothell, WA,
Duration: Months contract on W
% onsite
Work Schedule: Sunday-Wednesday, PM - :AM PST
Key Competencies -
Proficient in Documentation Review Degree in a Scientific Field Experience in a GMP setting
Candidates who have recently graduated with a degree in biology or a related field seeking GMP experience are encouraged to apply.
Responsibilities include maintaining a quality presence on the production floor; assessing in-process materials and final products; investigating and rectifying GDP discrepancies; conducting batch record evaluations. Ensures that manufactured products comply with all relevant regulations and standards. May assist in preparations for regulatory and customer audits.
Conducts general and complex reviews of manufacturing formulation batch production records and approves them to support product release in line with specifications and SOPs. Inspects and approves intermediates or packaged pharmaceutical products according to specifications. Monitors various stages of production along with the necessary documentation to ensure compliance with specifications. Drafts and reviews specifications and SOPs. Tracks and analyzes batch record discrepancies and provides Quality Assurance management with quality performance data. May offer guidance to junior staff members. Provides comprehensive support during daily inspections of GMP areas. Qualifications:
A degree in Biology, Chemistry, or a related field, or equivalent experience is preferred. A minimum of + years of relevant experience in a regulated environment, with at least years focused on product quality. Familiarity with biotech product manufacturing. Understanding of US and EU cGMP regulations and guidelines. Knowledge of Oracle, BMRAM, MES, and Veeva Infinity is advantageous.
