QA Document Control Specialist — GMP/Regulatory Ready

TechDigital Group; Bothell (WA); On-site; USD 50,000 - 80,000; Full time

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

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.