Sr. Specialist, Quality Assurance

Just is seeking a highly-motivated Sr. 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 to actively manage deviation and CAPA records through the electronic quality management system and to drive the maturation of the Deviation and CAPA programs. As the Business Process Owner, this individual will have the overall responsibility to enhance and sustain the Deviation and CAPA programs, ensuring compliance with internal requirements and external GMP regulations. 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.

Responsibilities

• Actively manage deviations and CAPAs to achieve on-time completion and to support right first time, operating cross-functionally to collect the necessary data and information to investigate root cause and determine the appropriate corrective action to prevent recurrence.
• Facilitate CAPA investigations, partnering with SMEs to define objectives, deliverables, ownership, due dates, and effectiveness monitoring requirements.
• Define, track, trend, and report program metrics.
• Develop and maintain phase-appropriate Quality processes for the Deviation and CAPA programs with respect to product lifecycle stages from early clinical development through the life of the product, including commercial launch, and post market approval.
• Manage quality initiatives that accomplish continuous improvement and enhance process efficiencies.
• Support and participate in internal and client audits and contribute to the development of responses to observations/questions.
• Drive quality responsibilities cross-functionally by developing and deploying training for the Deviation and CAPA programs.
• 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.
• 5+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.

Preferred Qualifications

• Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies to ensure compliance.
• Significant experience navigating and managing various modules in a Quality Management System software suite.
• Excellent verbal and technical writing skills.
• Strong focus on quality and attention to detail.
• Understands multiple RCA tools and when, where, and how to apply them.
• 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, and/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 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