D06 - QLTY Assurance Methods/Qa Methods MGMT - QA Document Control Labeling Specialist
Job in
Bothell, Snohomish County, Washington, 98021, USA
Listing for:
TechDigital Group
Full Time
position
Listed on 2025-12-14
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Salary/Wage Range or Industry Benchmark: 50000 - 80000 USD Yearly
USD
50000.00
80000.00
YEAR
Job Description & How to Apply Below
Position: D06 - QLTY ASSURANCE METHODS / QA METHODS MGMT - QA Document Control Labeling Specialist
Location: BothellJob Title:Quality Assurance Document Control (QADC) Associate Specialist
Location:
Bothell, WA
* Onsite
Shift: Friday
- Monday 2pm-10:30pm
Top
Skills:Strong communication and customer service skills.InnovationAble to prioritize, manage time well, multi-task, and troubleshoot effectivelySmartsheet and Excel experienceAbility to provide examples on how they have honed in on attention to detailReview of SOPs, procedures, edits and annotations within EDMS experienceThe 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:Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environmentStrong communication and customer service skills.Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principlesStrong 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 improvementAble to prioritize, manage time well, multi-task, and troubleshoot effectivelyAbility to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverablesPossess project management skills.Experience interacting with FDA or other regulatory agencies strongly preferredStrong knowledge of cGMPs and domestic regulatory requirementsKnowledge 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 networkSome labeling experience strongly preferredDUTIES AND RESPONSIBILITIES:Primary responsibilities include:
Issuing production batch records, labels, and other controlled documents to support manufacturing operationsResponsible 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 roomManaging an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective stateMay write and revise document control procedures including participating in the development and roll-out of document control toolsFollow Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requestsAssist with cross-training of Document Control personnel and customers to ensure adherence with proceduresExecute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the siteSupport 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 inspectionsPerform 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 dataProvide communication as to the status of Quality Systems deliverables to customers, management and stakeholdersWORKING 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.
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