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QA Specialist - DP and DS Lot Disposition

Employer
Just - Evotec Biologics
Location
Redmond, WA
Start date
Oct 27, 2022

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioForest

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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