Omni Inclusive | QA Associate Specialist - Document ...

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. • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures. • Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site. • Generate document management system reports for Quality Council metric reporting. • Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections. • Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders. • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles Position Reports to Jenna Walker - Associate Director, QA Training & Document Control Education: Bachelor's 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 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 manager of decisions outside of established processes and the ability to build an internal network.

Created: 2024-11-26