QA Document Control Specialist – Records & Compliance

Sunrise Systems, Inc.; Bothell (WA); On-site; USD 55,104 - 60,614; Part time

Benefits offered by this job

ACA-compliant medical, dental, and vision insurance

Sick time benefits as required per state regulations

Job summary

A leading document control provider located in Bothell, WA is seeking a QA Associate Specialist for Document Control. This role entails managing GMP records and supporting document approval processes, ensuring compliance with FDA/EMA regulations. Candidates should possess strong communication skills and a background in records management in regulated environments. The position offers a pay rate of $40–$44 per hour, along with ACA-compliant health benefits.

Qualifications

• Experience in a cGMP/FDA regulated environment.
• Demonstrated experience with quality management systems.
• High school diploma/associate’s degree with equivalent education acceptable.

Responsibilities

• Organize cGXP controlled document files for retrieval and archiving.
• Assist with Document Center Archive room activities.
• Support internal and external audits and inspections.

Skills

Strong communication and customer service skills

Experience with Part 11 adherence

Proficient in MS Office

Ability to prioritize and manage time

Strong knowledge of cGMPs

Experience in FDA/EMA regulations

Education

Bachelor's degree or equivalent

3+ years of document control experience

Tools

Document Management System

Content Manager Records Software

Job description

A leading document control provider located in Bothell, WA is seeking a QA Associate Specialist for Document Control. This role entails managing GMP records and supporting document approval processes, ensuring compliance with FDA/EMA regulations. Candidates should possess strong communication skills and a background in records management in regulated environments. The position offers a pay rate of $40–$44 per hour, along with ACA-compliant health benefits.