Quality Assurance Document Control
2 weeks ago
Pay Scale: $36.00 to $38.00 per Hourly
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.
- 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
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.
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