QA Document Control Specialist for Cell Therapy

TechDigital Group

Seattle (WA)

On-site

USD 60,000 - 90,000

Full time

7 days ago
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Job summary

An established industry player is seeking a Quality Assurance Document Control Associate Specialist to support cGMP Document Control operations. This role involves managing an electronic document system, ensuring compliance with regulatory standards, and supporting audits and inspections. The ideal candidate will have a strong background in document control within a regulated environment, excellent communication skills, and the ability to work collaboratively across departments. Join a dynamic team dedicated to quality and continuous improvement, where your contributions will help shape the future of cell therapy processes.

Qualifications

  • 1+ years of document control experience in a cGMP/FDA regulated environment.
  • Strong communication skills and ability to work cross-functionally.

Responsibilities

  • Manage electronic document system and document change requests.
  • Support internal and external audits and regulatory inspections.

Skills

Document Control & Reporting Experience
Technical troubleshooting
Self motivated
Great communication
Cross-functional collaboration

Education

Bachelor's degree or equivalent

Tools

MS Office (Word, Adobe, Visio, Excel)
Document Management System
Quality Management System

Job description

Top Skills:
1. Couchbase architecture, cluster administration, upgrades and L3 production support.
2. SQL++ performance tuning, indexing, XDCR, HA/DR, backup and recovery.
3. AWS, Linux, Python/Shell automation and enterprise troubleshooting.

Job Summary:
Senior Couchbase DBA / Architect required to design, administer and optimize enterprise Couchbase environments; provide L3 production support, performance tuning, HA/DR, upgrades, automation and architectural leadership.

Job Description/Responsibilities:
• Design scalable, secure, highly available Couchbase cluster architecture on-premises and in AWS.
• Administer clusters, upgrades, patching, rebalance, failover and production operations.
• Lead L3 troubleshooting, RCA, performance tuning, SQL++ query/index optimization.
• Design XDCR, backup/recovery, disaster recovery and capacity planning.
• Implement security controls, monitoring and Linux/Python/Shell automation.
• Partner with application, cloud and infrastructure teams; lead technical reviews and mentor DBAs.

Additional information:
Minimum 10+ years overall database experience; preferably 5+ years hands-on Couchbase. Senior hands-on architect / technical lead; production-critical environments. Deliverables: resilient architecture, operational stability, performance optimization, automation and incident resolution.
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