Quality Assurance Document Control
Education and
Experience:
- Bachelor's degree or equivalent.
- 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 behaviors 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 managers of decisions outside of established processes and the ability to build an internal network.
Skills :
- 2
years of Document Control & Reporting Experience. - Veeva experience preferred.
- Technical troubleshooting.
- Self motivated, independent, great communication.
- Experience working cross-functionally.
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