Quality Assurance Manager, Drug Product | Seattle, WA
Just is seeking a highly motivated QA Manager within the Quality Assurance group that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role is responsible for providing Quality oversight for the Drug Product Manufacturing services to ensure adherence to cGMP regulations, Just Quality Requirements, and Regulatory guidelines.
- Independently plan and manage all aspects of tech transfer and fill finish operations for Just – Evotec Biologics to fill finish CMOs
- Represent the client for review and approval of Quality controlled documents
- Review CMO batch records and provide oversight for all specified manufacturing
- Throughout ensure cGMP compliance and all its related elements in documentation, reports, and records
- Works closely with the CMO staff to investigate, document, and resolve compliance issues and deviations. Ensure deviations are thoroughly identified, defined, and properly assessed
- Work closely with Just Quality Assurance (QA) Operations with respect to Drug Product
manufacture, release, inventory management and distribution, and as pertains to vendor selection, qualification and monitoring and all other activities related to cGMP and ICH guidelines
- Interact with clients on presentations and project results; will also work closely with
clients during initial and subsequent manufacturing campaigns
- 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
- Sign documents for activities as authorized and described by Just policies and procedures.
- Perform tasks as requested by leadership to support Quality oversight activities
Qualifications and Educational Requirements
- B.S. in Engineering or Science discipline and 5-8 years of GMP biologic manufacturing experience. Some or all of this experience should be in fill/finish processing.
- Has excellent understanding and knowledge of all fill finish operations including aseptic hand filling and automated filling of liquid vials. Familiarity with lyophilized DP a plus.
- Has demonstrated track record of managing hands-on cGMP manufacturing operations
- Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules.
- Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles.
- Solid technical understanding of GMP biologics manufacturing processes and equipment.
- The ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
- 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 100 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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