QA Specialist, Change Control | Redmond, WA
Just-Evotec Biologics is seeking a highly-motivated QA Specialist within the Quality Systems group that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role is responsible for providing Change Control Quality oversight for issues of significant scope and complexity across the Just Manufacturing and Quality operations in order to ensure adherence to cGMP regulations, Just Quality Requirements, and ICH Q10 guidelines.
- Apply process/equipment expertise and solid understanding of applicable cGMP regulations to provide Quality oversight for GMP changes
- Support inspection readiness activities, Health Authority and Client audits, and drive corrective actions based on audit findings.
- Participate in the identification, design and implementation of department and cross-functional process/system improvement initiatives
- Serve as the Quality representative on cross-functional teams
- Apply advanced theory, technical principles, and expert judgment to independently address a broad range of problems
- Troubleshoot the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships
- Provide input to the development of personal performance goals
- Train internal groups on relevant business processes
- Sign documents for activities as authorized and described by Just policies and procedures
- Perform tasks as requested by leadership to support Quality oversight activities
- Apply change control functions, ensuring that each program is consistent with current regulatory and industry guidelines
- Review and approve Quality controlled documents
- Represent Quality Assurance Change Control on multi-disciplinary project teams
- Participate in deviation investigations as needed
- Participate in inspection preparation and audit support activities
- Ensure deviations are thoroughly identified, defined and properly assessed
- Interact with interdepartmental contacts on changes, deviation assessments, resolution, and Quality approval
- Assist with Quality leadership to support internal and external partners concerning the change record lifecycle
- Collaborate with departments to ensure review of changes is executed efficiently and effectively
- Identify and participate in the implementation of process improvements
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 Change Control guidelines set forth in ICH Q9 and Q10
- Experience with GMP biologics manufacturing processes and equipment.
- Ability to interpret and relate Quality Requirements for implementation and review
- Ability to communicate issues, ideas and results clearly and professionally in a comprehensive and concise manner both in writing and verbally. Ability to explain moderate issues and concepts with simplicity to a broad audience.
- Flexibility in problem solving and work hours with minimum guidance from leadership to meet business objectives
- The ability to work both independently and collaboratively with scientific 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.
About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, 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. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 200 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers
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