Quality - QA Associate Specialist Document Control

TechDigital Group; Bothell (WA); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Document Control Associate Specialist to support cGMP operations. In this role, you will be responsible for managing GMP records, ensuring compliance with regulatory standards, and facilitating the document approval process. The ideal candidate will have a strong background in document control within regulated environments and possess excellent communication and project management skills. Join a dynamic team where your contributions will enhance quality and efficiency in a fast-paced setting, making a significant impact on the organization's success.

Qualifications

• 5-8 years of experience in document control within cGMP/FDA environments.
• Strong computer skills and proficiency in MS Office and Quality Systems.

Responsibilities

• Organize cGXP controlled document files for easy retrieval.
• Manage the Document Center Archive room and ensure compliance.

Skills

Document Control Management

Communication Skills

Customer Service Skills

Project Management

cGMP Knowledge

Problem Solving

Education

Bachelor's Degree

Library Science

Tools

MS Office

Document Management System

Quality Management System

Adobe

Visio

Excel

Job description

Quality - QA Associate Specialist Document Control

Job #: 4934
Pay Rate: Not Specified
Job type: contractor
Location: Bothell, WA

PURPOSE AND SCOPE OF POSITION:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for Client Jump site records management. Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education: Bachelor's degree or equivalent. Library Science a plus.

Experience Basic Qualifications:
Minimum of 5 - 8 years of relevant document control records management experience in a cGMP/FDA regulated environment.
Strong communication and customer service skills.
Experience with Part 11 adherence regarding scanning of records and electronic archiving.
Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
Possess project management skills.
Strong knowledge of cGMPs and domestic regulatory requirements.
Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.

DUTIES AND RESPONSIBILITIES:

Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
Assist with managing the Document Center Archive room.
Thorough 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, and archive documents and document change requests.