Quality Assurance Associate, Document Management | Seattle, WA

Just is seeking a highly-motivated QA Associate 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 overseeing the end-to-end document management lifecycle for GMP records.  This not only includes managing document issuance, revision, superseding, and withdrawal but also assisting and providing oversight for GMP document authoring, retention, and archival.

Responsibilities

  • Manage the overall controlled document lifecycle including generation, approval, revision, archival, and obsolescence.
  • Oversee the batch record issuance program to provide manufacturing with quality issued batch records to execute manufacturing activities against.
  • Manage archival of manuals, documents, and other GMP related documents that require conversion to electronic format.
  • Support controlled document authors with the creation and revision of manufacturing documents, including but not limited to Batch Records, Quality Control methods, Manufacturing labels, Material Specifications, and Standard Operating Procedures (SOPs).
  • Partner with process engineering and manufacturing staff to develop user-friendly batch record templates.
  • 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. 
  • Help manage controlled documents in an EQMS and move them through the approval process.
  • Support inspection readiness activities, Health Authority and Client audits, and drive corrective actions based on audit findings.

Qualifications and Educational Requirements

  • Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering or related life science field.
  • 1 – 2+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
  • Word processing software certification or advanced experience using Microsoft Word software.

Preferred Qualifications

  • Strong focus on quality and attention to detail
  • GMP and compliance knowledge and experience with document control in a cGMP manufacturing setting
  • Previous experience working in upstream and/or downstream drug substance manufacturing
  • Technical writing including manufacturing documentation and Standard Operating Procedures
  • Excellent verbal and written communication skills
  • Experience working in a EQMS (Enterprise Quality Management Software) or EDMS (Electronic Document Management Software)
  • Ability to work independently and be self-directed
  • Agility to work in a dynamic environment with the ability to shift focus and priorities and work on a broad range of tasks simultaneously

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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