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Quality Assurance Document Control

5 months ago

Seattle, United States Integrated Resources Full time

Job Description: Top Skills:

- 2+ years of Document Control & Reporting Experience,

- Veeva experience preferred

- Technical troubleshooting

- Self motivated, independent, great communication

- Experience working cross-functionally

Position Summary:

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.

Duties/Responsibilities:

Primary responsibilities include:

Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.

May write and revise document control procedures including participating in the development and roll-out of document control tools.

Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.

Education: Bachelors degree or equivalent

Experience Basic Qualifications:

Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.

Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.

Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)

Experience interacting with FDA or other regulatory agencies strongly preferred.

Strong knowledge of cGMPs and domestic regulatory requirements.

Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).