Senior Specialist, Quality Assurance | Redmond, WA
Just is seeking a highly-motivated Compliance Specialist within the Quality group that desires to be part of a team focused on improving worldwide access to Biotherapeutics. This individual will join the Quality team at Just with their primary responsibility being the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The ability to work both independently and collaboratively with scientific and manufacturing staff across multiple disciplines in a fast-paced and dynamic environment are essential to be successful in this position.
- Provide Quality and Compliance oversight to support product manufacturing, release, and disposition operations to ensure compliance with early and late-stage clinical drug substance GMP manufacturing.
- Support and collaborate with manufacturing staff on the floor and with Quality assurance to understand the manufacturing process and relevant regulatory requirements to continuously improve operations.
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures, and instructions for all activities in which the team participates.
- Works collaboratively with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance.
Qualifications and Educational Requirements
- Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, or related life science field.
- 2 – 5+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
- Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies to ensure compliance.
- Excellent verbal and written communication skills.
- Strong focus on quality and attention to detail.
- Possess effective task/time management organization skills.
- GMP and compliance knowledge and experience with process and/or analytical validation in a cGMP manufacturing setting
- Previous experience working in Quality Assurance, Quality Control, or Drug Substance or Drug Product manufacturing
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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