Job Title : Quality Assurance Document Control (QADC) Associate Specialist

Location : Bothell, WA 98021

Duration : 6 Months

Shift- Sunday - Thursday 10 : 00pm - 6 : 30am

Top Skills :

Strong communication and customer service skills.

Innovation

Able to prioritize, manage time well, multi-task, and troubleshoot effectively

Smartsheet and Excel experience

Ability to provide examples on how they have honed in on attention to detail

Review of SOPs, procedures, edits and annotations within EDMS experience

Job Description :

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.

Education : Bachelor s degree or equivalent

Experience Basic Qualifications :

Minimum of 1 year of relevant document control management experience in a cGMP / FDA regulated environment

Strong communication and customer service skills.

Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles

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.

Experience interacting with FDA or other regulatory agencies strongly preferred

Strong knowledge of cGMPs and domestic regulatory requirements

Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)

Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network

Some labeling experience strongly preferred

Duties and Responsibilities :

Primary responsibilities include :

Issuing production batch records, labels, and other controlled documents to support manufacturing operations

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

Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and and releasing documents to an effective state

May write and revise document control procedures including participating in the development and roll-out of document control tools

Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures

Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site

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

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

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.

Last updated : 2024-05-20