QA Document Control & Labeling Specialist (Onsite)

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 support cGMP Document Control operations. This role involves managing document change control processes, issuing batch records, and ensuring compliance with regulatory requirements. The ideal candidate will possess strong communication skills, attention to detail, and a proactive approach to problem-solving. Join a dynamic team where your contributions will enhance quality assurance processes and support manufacturing operations. This is an exciting opportunity to work in a fast-paced environment and collaborate across departments to ensure the highest standards of quality are met.

Qualifications

• Minimum of 1 year of relevant document control management experience.
• Strong knowledge of cGMPs and domestic regulatory requirements.

Responsibilities

• Issuing production batch records and controlled documents.
• Managing an electronic document system for the JuMP site.
• Supporting internal and external audits and regulatory inspections.

Skills

Strong communication and customer service skills

Innovation

Time management and multitasking

Attention to detail

Smartsheet experience

Excel experience

Technical writing skills

Project management skills

Education

Bachelor's degree or equivalent

Tools

MS Office (Word, Adobe, Visio, Excel)

Document Management System

Quality Management System

Job description

An established industry player is seeking a Quality Assurance Document Control Associate Specialist to support cGMP Document Control operations. This role involves managing document change control processes, issuing batch records, and ensuring compliance with regulatory requirements. The ideal candidate will possess strong communication skills, attention to detail, and a proactive approach to problem-solving. Join a dynamic team where your contributions will enhance quality assurance processes and support manufacturing operations. This is an exciting opportunity to work in a fast-paced environment and collaborate across departments to ensure the highest standards of quality are met.