QA Associate Specialist Document Control

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.