QA Scientist

Nwrpros Bothell , WA 98021

Posted 2 months ago

Our Client is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market.
SUMMARY:
TheQA Scientist will provide technical and scientific expertise in support of activities associated with the re-establishment and startup of a commercial GMP Biologics Facility. Duties for this role include support of operational readiness activities, review of process and facility validation strategy, investigation and closure of quality events including Deviation, CAPA, and Change Control as well at master batch record approval. The QA Scientist also supports routine manufacturing operations, customer project teams, and efforts in continuous improvement.
PRINCIPAL RESPONSIBILITIES:
  • Demonstrates success using compliance knowledge, creativity and regulatory perspectives to solve problems
  • Exercises judgment within generally defined practices and policies in interpreting and applying regulations to GMP systems
  • Interprets regulations and guidelines critical for advancement of QA systems
  • Independently leads compliance assessments and oversight associated with validation and facility startup of facility and review of associated documentation required to startup and maintain the facility and production
  • Takes an active role in planning and implementation of QA long range goals for further development of key QA initiatives
  • Accountable for decisions and results that ensure timelines are met
  • May lead projects or represent QA interests in multidisciplinary project teams.
  • Works closely with other team members in a cooperative fashion to ensure project progression and timeline adherence
  • May support and contribute to the direction and decisions of project teams
  • Responsible for making recommendations in accordance with regulatory expectations and industry standards
KNOWLEDGE, SKILLS & ABILITIES:
  • Must possess strong technical and analytical understanding of Biologics Manufacturing and testing
  • Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques
  • Knowledge of scientific principles and concepts as they relate to GMP Operations
  • Knowledge of CAPA, change control and deviation programs and requirements
  • Great team player who is collaborative and positive
  • Ability to understand and apply GMP regulations as they relate to manufacturing, analytical testing and facility operations
  • Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated
  • strong interpersonal, written/oral communication and problem solving skills
EDUCATION/EXPERIENCE:
  • BA or BS with at least 10 years QA-related experience or equivalent work experience or a PhD in a scientific discipline with at least 2 years related experience; may include post-doctoral experience or equivalent work experience
  • Experience with application of compliance principles which drive QA strategy
  • Experience in change control facilitation and closure
  • Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure
  • Equivalent education and experience may substitute for stated requirements
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QA Scientist

Nwrpros