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QA Associate Specialist Document Control - Summit, United States - Sunrise Systems
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.
Education:
Bachelors degree or equivalent
Experience Basic Qualifications:
Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
Strong communication and customer service skills.
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)
Must demonstrate the following behaviours consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
Possess project management skills.
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.).
Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.