Document Control Specialist

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

QA Associate Specialist – Document Control

Location: Bothell, WA

Position Type: Hourly contract position (W2 only)

Pay Rate: $40–$44 per hour on W2

Work Schedule: Sunday – Thursday

Position Summary

The Quality Assurance – Records Management supports the cGMP Document Control operations for BMS Bothell site records management. Responsibilities include receiving and reconciling GMP records, managing scanning, archival, and retention of GMP records.

Duties and Responsibilities

• Responsible for organizing cGXP controlled document files within the Document Center and ensuring records are readily retrievable and sent to the final archive facility as needed.
• Assist with Document Center Archive room activities.
• Apply knowledge of Records Management, Scanning, and organization functions.
• Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, archive documents, and document change requests.
• Execute process and procedures for identifying, collecting, distributing, and filing controlled documents for the site.
• Support internal and external audits and regulatory inspections, which may require data gathering, interviewing, or escorting auditors during the audit.
• Assist with document retrieval/organization support during regulatory inspections.
• Assist with insurance and reconciliation of controlled forms and logbooks.

Qualifications

• Strong communication and customer service skills.
• Experience with Part 11 adherence regarding scanning of records and electronic archiving.
• Proficient in MS Office (Word, Adobe, Visio, Excel) and Quality Systems (e.g., Document Management System, Quality Management System).
• Demonstrates innovative, proactive, and resourceful behaviors; committed to quality and continuous improvement.
• Ability to prioritize, manage time, multi‑task, and troubleshoot effectively.
• Effective and collaborative work at a fast pace with cross‑functional departments to finalize time‑sensitive deliverables.
• Strong knowledge of cGMPs and domestic regulatory requirements.
• Independent in completing tasks, notifying manager of decisions outside established processes, and building an internal network.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.
• Demonstrated experience with quality management systems.
• Experience with at least one enterprise computer‑related system used for recording Quality System data (e.g., Content Manager Records Software).

Education and Related Work Experience

• Bachelor’s degree or equivalent (Library Science is a plus). High school diploma / associate’s degree with equivalent education and work experience may be considered.
• Minimum of 3+ years of relevant document control records management experience in a cGMP/FDA regulated environment.

Working Conditions (US Only)

• Normal office working conditions.
• Duties are largely cognitive, with occasional minimal motor skills for moving objects, operating a computer, keyboarding, or word processing.
• This job description describes general duties; additional job‑related duties may be assigned by management.

Compensation

The hourly rate for this position is between $40.00 – $44.00 per hour.

Benefits

• ACA‑compliant medical, dental, and vision insurance for all employees.
• Sick time benefits as required per state regulations.