Quality Assurance Document Control (QADC) Associate Specialist

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

Quality Assurance Document Control (QADC) Associate Specialist

Job #: 3240
Pay Rate: Not Specified
Job type:
Location: Bothell, WA

Top Skills:

1. Strong communication and customer service skills.
2. Innovation
3. Able to prioritize, manage time well, multi-task, and troubleshoot effectively
4. Smartsheet and Excel experience
5. Ability to provide examples on how they have honed in on attention to detail
6. Review of SOPs, procedures, edits and annotations within EDMS experience

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education: Bachelor's degree or equivalent
Experience Basic Qualifications:

1. Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment
2. Strong communication and customer service skills.
3. Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles
4. 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)
5. Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
6. Able to prioritize, manage time well, multi-task, and troubleshoot effectively
7. Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
8. Possess project management skills.
9. Experience interacting with FDA or other regulatory agencies strongly preferred
10. Strong knowledge of cGMPs and domestic regulatory requirements
11. Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
12. Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network
13. Some labeling experience strongly preferred

DUTIES AND RESPONSIBILITIES:
Primary responsibilities include:

1. Issuing production batch records, labels, and other controlled documents to support manufacturing operations
2. 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.
3. Assist with managing the Document Center Archive room
4. Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state
5. May write and revise document control procedures including participating in the development and roll-out of document control tools
6. 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
7. Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures
8. Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site
9. Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections
10. Perform Document Control metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data
11. Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders

WORKING CONDITIONS (US Only):
Employees holding this position will be required to perform job-related duties supporting the Manufacturing Operations, related to batch documentation to support the various Manufacturing shifts. Weekend and off-shift support may be required.