QA Specialist - DP and DS Lot Disposition
- Employer
- Just - Evotec Biologics
- Location
- Redmond, WA
- Start date
- Oct 27, 2022
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- Discipline
- Clinical, Clinical Medicine, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioForest
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Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products
Responsibilities:
- Execute product disposition and release of Drug Substance (DS) / Drug Product (DP) and intermediates
- Manage the QA communication and lot disposition process with CDMO client base
- Support QA review and approval of Master Batch Records, Executed Batch Records, EBRs, Product Specifications and Quality Control Analytical data.
- Responsible for creation, review, and signature of Drug Substance / Drug Product CoAs (certificate of analysis) and CoCs (certificate of compliance)
- Review and provide feedback on the disposition requirement section for Quality Agreements
- Support internal and client audits of the quality management systems
- Alert senior management of significant quality, compliance, supply and safety risks
Educational Requirements:
- Bachelor’s degree in biological or engineering science with 2+ years relevant experience
Preferred Qualifications:
- Product disposition experience
- Quality Assurance experience
- Understanding of biologics regulatory requirements, risk management principles, and science-based decision making
- Knowledge in tools, concepts, and methodologies of QA
- Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
- Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams
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