QA Specialist Deviations and CAPA

Profile

Just-Evotec Biologics is seeking a highly motivated QA Specialist 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 Deviation, Nonconformance, and CAPA records. This includes managing record initiation, facilitating and performing investigations, assessing root causes, determining correction actions, and preparing detailed Quality System records.

Responsibilities:

• Initiating records in Just’s EQMS in response to notifications from functional areas.
• Participating and leading triage meetings to determine actions to be taken in response to deviations and nonconformances.
• Coordinating and managing deviation task completion, managing deviation and CAPA records to completion.
• Root cause analysis and classification, development of effective CAPA to address root causes.
• Preparing deviation records for quality review and approval.
• Participate in and help implement deviation and compliance improvement projects, including SOP revisions and Change Control management.
• Provide input to the development of personal performance goals.
• 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 Biopharmaceutical Industry.

• 3-5 years of relevant experience in a Biopharmaceutical cGMP manufacturing or similar environment.
• Sound knowledge of cGMPs and Document Control guidelines set forth in ICH Q7 and Q10
• Experience with GMP biologics manufacturing processes and equipment.
• Ability to communicate issues, ideas and results clearly and professionally in a comprehensive and concise manner both in writing and verbally. Ability to explain complex issues and concepts with simplicity to a broad audience.
• The ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
• Critical thinker with a comprehensive understanding risk management applications.
• Significant experience navigating and managing various modules in a Quality Management System software suite.

• Strong focus on Quality and attention to detail.

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