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QA Specialist - DS Lot Disposition

Employer
Just - Evotec Biologics
Location
Seattle, WA
Start date
Sep 10, 2022

View more

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

QA Specialist - DS Lot Disposition

Location: Seattle

Full-Time

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) / Placebo/ Cell Banks, 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, 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 3+ years relevant experience

Preferred Qualifications:

  • Product disposition experience
  • Understanding of biologics regulatory requirements, risk management principles, and science-based decision making
  • Knowledge in tools, concepts, and methodologies of QA
  • Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams
  • Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES


Worker

Company

Just - Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

Find Us
Phone
206-651-5094
Location
401 Terry Avenue North
Seattle
98109
US
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