QA Document Control Specialist — GMP/Regulatory Ready

TechDigital Group

Bothell (WA)

On-site

USD 50,000 - 80,000

Full time

9 days ago

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Job summary

An established industry player is seeking a Quality Assurance Document Control Associate Specialist to enhance their cGMP Document Control operations. In this pivotal role, you will manage document change control processes, oversee batch records, and ensure compliance with regulatory standards. Your attention to detail and strong communication skills will be essential in collaborating with cross-functional teams and supporting internal audits. If you thrive in a fast-paced environment and are passionate about quality and continuous improvement, this opportunity is perfect for you. Join a dynamic team dedicated to excellence and innovation in document management.

Qualifications

  • 1+ year of document control management experience in a cGMP/FDA environment.
  • Strong computer skills with MS Office and Quality Systems.

Responsibilities

  • Issuing production batch records and controlled documents.
  • Managing electronic document system and supporting audits.

Skills

Strong communication and customer service skills
Innovation
Time management and multi-tasking
Smartsheet and Excel experience
Attention to detail
SOP review and document management

Education

Bachelor's degree or equivalent

Tools

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

Job description

Objective
Identify a DevOps engineer capable of designing and implementing end-to-end CI/CD and cloud infrastructure, with a strong emphasis on the Azure ecosystem, automation, and migration from ADO to GitHub Actions.

Must-haves:
• Strong recent hands-on experience in Microsoft Azure (preferred over AWS).
• Expertise in CI/CD tools:
o Azure DevOps (ADO)
o GitHub & GitHub Actions
o JFrog Artifactory
• Hands-on experience with Infrastructure as Code (Terraform)

Key Responsibilities
• Design and implement end-to-end CI/CD pipelines across Azure DevOps, GitHub, and GitHub Actions.
• Lead migration from Azure DevOps (ADO) to GitHub Actions, including repository and artifact transition using JFrog.
• Architect and deliver cloud infrastructure solutions (cloud/on-prem/hybrid) with a strong automation orientation.
• Build scalable and reusable DevOps automation frameworks using Terraform.
• Implement and manage containerized environments using Docker and Kubernetes (AKS).
• Drive CI/CD best practices including pipeline standardization, automation, and optimization.

Mandatory Skills (Must Have)
• Strong recent hands-on experience in Microsoft Azure (preferred over AWS).
• Expertise in CI/CD tools:
o Azure DevOps (ADO)
o GitHub & GitHub Actions
o JFrog Artifactory
• Hands-on experience with Infrastructure as Code (Terraform)
• Deep understanding of Azure Kubernetes Service (AKS) and networking/integration concepts.
• Strong experience in Linux, Docker, and containerization.

Desired Skills (Good to Have)
• Experience with GitLab (indicative of GitHub Actions adaptability).
• Knowledge of hybrid/cloud infrastructure architectures.

Key Evaluation Criteria
Use the below to screen profiles quickly:
Area: What to Look For
Cloud Platform: Strong Azure experience (recent hands-on)
CI/CD Proven design of pipelines using GitHub Actions + ADO
Migration Experience: ADO → GitHub Actions transformation
Automation: Terraform-led infrastructure automation
Containers: AKS + Docker + Kubernetes expertise
Artifacts: Experience with JFrog integration
End-to-End Ownership: Designed full CI/CD + infrastructure stack
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