QA Documentation Specialist

1 week ago

Bothell, United States Integrated Resources, Inc ( IRI ) Full time

Title: Quality Assurance Specialist


Location: Bothell, WA


Duration: 12+ months



Job Description:

  • In your role, you have the all-important task of preparation and review of required procedures, documentation, and retention practices, supporting inspections, and supporting ongoing continuous improvement and compliance efforts.
  • Perform procedural administration activities within the Global Documentation Management System.
  • Partner with PharmSci business lines in the development, implementation, and management of their procedures, documentation and records.
  • Support the management of Active libraries and other documentation systems (e.g. Document Long Term Storage) for PharmSci to ensure adequate control of physical and electronic records, including logbook issuance and reconciliation.
  • Manage the inventory of records within the Central Index of Company Records (CICR) system to support the creation, management, retention, and disposal of company records and information.
  • Partner with the Enterprise Records and Information Management (eRIM) team to ensure alignment with record retention policies and legal holds.
  • Partner with the off-site Record Service Centers (PRSC) to manage the lifecycle of company records and to ensure robust process for retrieval of records in support of audits and inspections.
  • Provide document technical writing, editing, and design support to other team members and supported site departments.
  • Work closely with project teams to ensure that documents are accurate, internally consistent, and meet intended purpose.
  • Prepare documents in accordance with internal standards and external regulatory guidelines.
  • Support equipment change controls, management of calibration/PM schedules, and coordination of associated documentation.


Must-Have

  • 1+ years of experience.
  • Understanding of cGMP, Data Integrity, and ALCOA principles.
  • Strongly skilled in word processing and document formatting; very experienced in Microsoft Office applications (Word, Excel, PowerPoint, Visio).


Nice-to-Have

  • Relevant pharmaceutical experience.
  • Demonstrated technical writing experience is desirable.
  • Strong project management skills.


Physical/Mental Requirements:

  • Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus, communication 1:1 and with larger groups).
  • Ability to independently solve problem and make recommendations for solutions.
  • Role is primarily office-sitting, standing, walking, and bending. T
  • his may be inclusive of leading/participating in Webex.


What is the minimum education experience required? HS

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