QA Associate Specialist – Document Control

TechDigital Group; Seattle (WA); On-site; USD 55,000 - 85,000; Full time

Job summary

An established industry player is seeking a detail-oriented QA Associate Specialist to enhance their Document Control operations. This role is vital in supporting the cGMP Document Control processes, including document approvals and change control. The ideal candidate will possess strong communication skills and a proactive mindset, ensuring compliance with regulatory standards while working collaboratively across departments. Join a dynamic team where your contributions will directly impact quality assurance and operational excellence in a fast-paced environment. If you're passionate about quality and continuous improvement, this opportunity is perfect for you.

Qualifications

• 1+ year of document control experience in a cGMP/FDA regulated environment.
• Strong communication and customer service skills required.

Responsibilities

• Manage electronic document system and document change requests.
• Support audits and regulatory inspections as needed.
• Generate reports for Quality Council metric reporting.

Skills

Document Control

Technical troubleshooting

Communication

Cross-functional collaboration

Self-motivated

Education

Bachelor's degree or equivalent

Tools

MS Office

Document Management System

Quality Management System

Adobe

Visio

Excel

Job description

QA Associate Specialist – Document Control

Top Skills:

1. 2+ years of Document Control & Reporting Experience
2. Veeva experience preferred
3. Technical troubleshooting
4. Self-motivated, independent, great communication
5. 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:

1. 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.
2. May write and revise document control procedures including participating in the development and roll-out of document control tools.
3. 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.
4. Assist with cross-training of Document Control personnel and customers to ensure adherence to procedures.
5. Execute the process and procedures for identifying, collecting, distributing, and filing the controlled documents for the site.
6. Generate document management system reports for Quality Council metric reporting.
7. Support internal and external audits and regulatory inspections if required. Assist with document retrieval/organization support during regulatory inspections.
8. Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
9. 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:

1. Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
2. Strong communication and customer service skills.
3. Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
4. 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).
5. Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
6. Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
7. Ability to work effectively and collaboratively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.
8. Possess project management skills.
9. Experience interacting with FDA or other regulatory agencies strongly preferred.
10. Strong knowledge of cGMPs and domestic regulatory requirements.
11. Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
12. Must complete tasks independently, notify manager of decisions outside of established processes, and the ability to build an internal network.