QA Specialist, Document Management 

Location
Redmond, WA, United States
Posted
Aug 27, 2020
Ref
1682744454
Hotbed
BioForest
Required Education
Masters Degree/MBA
Position Type
Full time
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 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:
  • Write and revise manufacturing documents, including but not limited to Batch Records, Quality Control methods, Manufacturing labels, Material Specifications, and Standard Operating Procedures (SOPs).
  • Manage the overall controlled document lifecycle including generation, approval, revision, archival, and obsolescence.
  • Support inspection readiness activities, Health Authority and Client audits, and drive corrective actions based on audit findings.
  • Verify a document is ready for final approval by ensuring proper review has been completed, document is on the current effective template, and all formatting is consistent.
  • Manage archival of manuals, documents, and other GMP related documents that require conversion to electronic format.
  • 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.
  • Assist in developing technical writing guidelines for GMP documents.
  • 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

Qualifications and Educational Requirements:
  • 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.
  • Word processing software certification or advanced experience using Microsoft Word software.
  • Sound knowledge of cGMPs and Document Control guidelines set forth in ICH Q7 and Q10
  • Experience with GMP biologics manufacturing processes and equipment.
  • Ability to communicate issues, ideas and results clearly and professionally in a comprehensive and concise manner both in writing and verbally. Ability to explain complex issues and concepts with simplicity to a broad audience.
  • 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 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