Website Universal Cells-Astellas Pharma

Turning innovative science into medical solutions

Purpose & Scope:

The primary purpose of the Quality Systems Associate I is to support the Quality Assurance team in maintaining Standard Operating Procedures, Batch Records, Forms, Templates, Process Support Documentation & Training Materials. This position will have opportunities to train team members and integrate compliance initiatives cross-functionally and identify areas for quality improvements.

Essential Job Responsibilities: 

  • Maintains and optimizes Quality Assurance programs including (but not limited to) document control, lot disposition, incident management and material management.
  • Maintains Standard Operating Procedures, Batch Records, Forms/Templates, Process Support Documentation & Training Materials
  • Edits documentation for clarity, consistency, organization, and effectiveness
  • Performs Executed Logbook and Executed Batch Record reviews
  • Works directly with Subject Matter Experts to develop content or provide meaningful feedback to improve structure and flow of documentation
  • Participates in customer meetings and identifies required potential changes to documentation, takes meeting minutes and communicates status to cross-functional audiences
  • Develops training materials, generates document solutions for optimization and risk mitigation, creates improved communication mechanisms
  • Performs other duties as assigned or special projects as needed

Quantitative Dimensions:

  • Direct impact on the company’s Quality Systems

Organizational Context:

  • Reports to Quality Assurance Management
  • Collaborates regularly with Production and R&D teams

Basic Qualifications:

  • BA/BS degree or equivalent work experience in Quality Assurance.
  • Strong attention to detail and accuracy of work.
  • Ability to explain and interpret information from internal and external sources
  • Ability to think quickly and perform complex tasks
  • Comfort executing routine tasks and generating work instructions to train peers
  • Cross-functional communication skills and positive attitude with customer service focus
  • Strong organizational, time management, and problem solving skills
  • Ability to work independently with supervision and ability to effectively collaborate with other teams
  • Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment

Preferred Qualifications:

  • Preferably 1-2 years of related Quality Assurance experience working in a lab environment
  • GMP/GLP experience preferred
  • Familiarity with electronic databases (for example: EDMS, SharePoint, Trackwise)
  • Experience writing Standard Operating Procedures (SOPs) and Production Batch Records
  • Biology or Bio-engineering background related to stem cell culturing, plasmid and rAAV production and product development is preferable

To apply for this job please visit