- 1 to 3 years of Document Control experience in a regulated environment
- 1 to 3 years of EDMS Experience(Veeva or similar Electronic Doc Management System)
- 1 to 3 years with MS Office 365(Specifically Word styles and formatting)
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Document Control Specialist
1 week ago
LanceSoft, Inc. Bothell, United StatesJob 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 tim ...
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Document Control Administrator
2 weeks ago
Skanska Bothell, United StatesPosition OverviewGeneral Position SummaryThe Document Control Coordinator shall be skilled in the use of technology to complete their day to day tasks. He/she is largely responsible for independently administering and managing the project document control system(s) including the ...
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Document Control Specialist
1 week ago
SSi People Bothell, United StatesRole: Quality Assurance Document Control · Location: Bothell, WA · Contract: 6 Months · Shift- Sunday - Thursday 10:00pm - 6:30am · Top Skills: · communication and customer service skills. · to prioritize, manage time well, multi-task, and troubleshoot effectively. · and Excel ex ...
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Document Control Specialist
1 week ago
LanceSoft Bothell, United StatesJob 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, man ...
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Document Control Specialist
1 week ago
LanceSoft Bothell, United StatesJob 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, man ...
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Document Control Specialist
2 days ago
Synkriom Bothell, United StatesJob Description · Job DescriptionTop 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 hav ...
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Document Control Specialist
1 week ago
Synkriom Bothell, United StatesJob Description · Job DescriptionTop 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 hav ...
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Quality Assurance Document Control
1 week ago
Pyramid Consulting, Inc Bothell, United StatesImmediate need for a talented Quality Assurance Document Control (QADC) Associate Specialist. This is a 12+ months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are int ...
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QA Document Control Specialist
1 week ago
Integrated Resources, Inc ( IRI ) Bothell, United StatesJob Title: QA Document Control Specialist · Location: Bothell, WA · 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 ...
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Quality Assurance Document Control
1 week ago
Pyramid Consulting, Inc Bothell, United StatesImmediate need for a talented Quality Assurance Document Control (QADC) Associate Specialist. This is a 12+ months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are intereste ...
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Quality Assurance Document Control
1 week ago
Omni Inclusive Bothell, United StatesTop 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 d ...
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QA Document Control Specialist
1 week ago
Primary Talent Partners Bothell, United StatesPrimary Talent Partners has a 6-month contract opening for a QA Document Control Specialist to join a global biopharmaceutical client of ours in Bothell, WA. · Shift: Sunday - Thursday 10:00pm - 6:30am · Note: No C2C or sponsorship is provided · Pay: $52 - $56.50 per hour depe ...
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Quality Assurance Document Control
2 days ago
On-Board Companies Bothell, United StatesOn-Board Services is hiring a · Quality Assurance Document Control (QADC) Associate Specialist · in Bothell, WA · For immediate consideration please send your resume to · Subject Line: Position Title and State you are Located. · About Us: · On-Board Services, Incorporated is an ...
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Quality Assurance Document Control
1 week ago
LanceSoft Bothell, United StatesJob Title: Quality Assurance Document Control (QADC) Associate SpecialistLocation: Bothell, WA 98021Duration: 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-ta ...
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QA Document Control Specialist
5 days ago
Primary Talent Partners, Inc. Bothell, United States6 days ago · Be among the first 25 applicants · Primary Talent Partners has a 6-month contract opening for a QA Document Control Specialist to join a global biopharmaceutical client of ours in Bothell, WA. · Shift: Sunday - Thursday 10:00pm - 6:30am · Note: No C2C or sponsorsh ...
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Quality Assurance Document Control
1 week ago
LanceSoft Bothell, United StatesJob 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 ...
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Document Control Specialist II
1 week ago
Verathon Bothell, United States· Document Control Specialist II · Location · US-Bothell · ID · Category · Quality Assurance/Regulatory Affairs · Position Type · Full-Time · Work Model · Onsite · Company Overview · Verathon is a global medical device company focused on supporting customers by being their ...
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Quality Assurance Document Control
2 days ago
Artech Bothell, United StatesJob Title: Quality Assurance Document Control (QADC) Associate Specialist · Location: Bothell, WA Onsite · Sunday - Thursday 10:00 pm - 6:30 am · 06+ Months contract · Pay rate: $56.53/hr on W2 · Top Skills: · • Strong communication and customer service skills. · • Innovation · • ...
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Quality Assurance Document Control
1 week ago
Synkriom Bothell, United StatesJob Description · Job DescriptionTop 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 hav ...
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Quality Assurance Document Control
1 week ago
Synectics Inc Bothell, United StatesJob Description · Job DescriptionJob Description: · Supports the cGMP Document Control operations for the Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and re ...
Quality - QA Associate Specialist Document Control - Bothell, United States - TechDigital Corporation
Description
Job Title:
Quality Assurance Document Control (QADC) Associate Specialist
Location:
Bothell, WA*Onsite
Top Skills:
PLEASE DO NOT SUBMIT CANDIDATES THAT HAVE PREVIOUSLY BEEN DISQUALIFIED FOR THIS ROLE
PURPOSE AND SCOPE OF POSITION:
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:
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.
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
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.
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