11 Quality Assurance Document Control (QADC) Associate Specialist Jobs in Bothell, WA
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Quality Assurance Document Control (QADC) Associate Specialist
$82k-101k (estimate)
Full Time | Business Services
2 Weeks Ago
LanceSoft Inc is Hiring a Quality Assurance Document Control (QADC) Associate Specialist Near Bothell, WA
Job Title: Quality Assurance Document Control (QADC) Associate SpecialistLocation: Bothell, WA 98021Duration: 6 MonthsShift- Sunday - Thursday 10:00pm - 6:30amTop Skills
Education: Bachelor’s degree or equivalent
Experience Basic Qualifications
- 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
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
- 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
- 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
- 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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$82k-101k (estimate)
POST DATE
05/18/2024
EXPIRATION DATE
06/08/2024
WEBSITE
lancesoft.com
HEADQUARTERS
HERNDON, VA
SIZE
500 - 1,000
FOUNDED
2000
TYPE
Private
CEO
DIVYA GANDHI
REVENUE
$200M - $500M
INDUSTRY
Business Services
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About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
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