QA Manager, Deviations and CAPA
Company: Just - Evotec Biologics
Posted on: May 7, 2022
Just-Evotec Biologics is seeking a highly motivated QA Manager
within the Quality Operations group that desires to be part of a
team focused on improving worldwide access to Biotherapeutics! The
role is responsible for overseeing the end-to-end management
lifecycle for the Deviation, Nonconformance, and CAPA records and
overseeing the programs from a quality
- Overall responsibility for deviation and CAPA management
- Working with functional areas to determine actions to gather
data and investigation content.
- Participating in client communication around deviations and
- Root cause analysis and classification, development of
effective CAPA to address root causes.
- Preparing deviation records for review and approval.
- Monitoring and tracking performance metrics related to
deviations and CAPAs.
- Participate in and help implement deviation and compliance
improvement projects, including SOP revisions and Change Control
- Providing input on the development of personal performance
- Train internal groups on relevant business processes.
- Perform tasks as requested by leadership to support Quality
oversight activities.Qualifications and Educational Requirements
- B.S. or M.S. degree, preferably in Engineering, Life Science,
or an equivalent combination of education and experience in the
- 5+ years of relevant experience in a Biopharmaceutical cGMP
manufacturing or similar environment. Previous experience with
writing and/or review of deviation and CAPA records preferred.
- Sound knowledge of cGMPs and Document Control guidelines set
forth in ICH Q7 and Q10.
- Knowledgeable user of Root Cause Analysis tools (5 Why,
- Experience with GMP biologics manufacturing processes and
- Ability to communicate issues, ideas, and results clearly and
professionally in a comprehensive and concise manner both verbally
and in writing. Ability to explain complex issues and concepts with
simplicity to a broad audience.
- Ability to guide staff and provide leadership across all levels
of the organization.
- The ability to work both independently and collaboratively with
scientific, operational, quality, and engineering staff across
multiple disciplines in a fast-paced and dynamic environment.
- Significant experience navigating and managing various modules
in a Quality Management System software suite.
- Strong focus on Quality and attention to detail.Middle
Keywords: Just - Evotec Biologics, Redmond , QA Manager, Deviations and CAPA, Executive , Redmond, Washington
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