- 2+ years of Document Control & Reporting Experience,
- Veeva experience preferred
- Technical troubleshooting
- Self motivated, independent, great communication
- Experience working cross-functionally
- Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting 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.
- Generate document management system reports for Quality Council metric reporting.
- Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.
- Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
- Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles
- Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
- Strong communication and customer service skills.
- Some technical writing skill set including the ability 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.
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QA Document Control
3 weeks ago
TSR Consulting Seattle, United StatesOur client, an established pharmaceutical company is in search of a QA Document Control Specialist to join their team on a W2 contract in Seattle, WA. · Position Summary: · The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control opera ...
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Document Control Specialist
1 week ago
Jimale Technical Services (JTS) Seattle, United StatesDOCUMENT CONTROL SPECIALIST · Position located in Seattle, Washington · JTS does not anticipate providing sponsorship for employment visa status (e.g. H-1B, OPT) for this position. · NO RECRUITERS PLEASE · JTS is currently seeking a candidate for a Document Control Specialist ...
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Document Control Specialist
3 weeks ago
Jimale Technical Services (JTS) Seattle, United StatesDOCUMENT CONTROL SPECIALIST · Position located in Seattle, Washington · JTS does not anticipate providing sponsorship for employment visa status (e.g. H-1B, OPT) for this position. · NO RECRUITERS PLEASE · JTS is currently seeking a candidate for a Document Control Specialist ...
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Document Control Specialist
2 weeks ago
Jimale Technical Services (JTS) Seattle, United StatesDOCUMENT CONTROL SPECIALIST · Position located in Seattle, Washington · JTS does not anticipate providing sponsorship for employment visa status (e.g. H-1B, OPT) for this position. · NO RECRUITERS PLEASE · JTS is currently seeking a candidate for a Document Control Specialist pos ...
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Document Control Specialist
2 weeks ago
System One Holdings, LLC Seattle, United StatesJob Title: Document Control Specialist · Location: Seattle, WA · Compensation: $ $37.35/hr · Type: Contract, Potential for extension or conversion to permanent · Responsibilities Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing a ...
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Document Control Specialist
1 week ago
Jimale Technical Services (JTS) Seattle, United StatesJob Description · Job DescriptionDOCUMENT CONTROL SPECIALIST · Position located in Seattle, Washington · JTS does not anticipate providing sponsorship for employment visa status (e.g. H-1B, OPT) for this position. · NO RECRUITERS PLEASE · JTS is currently seeking a candidate for ...
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QA Associate Specialist – Document Control
2 weeks ago
Sunrise Systems Inc Seattle, United StatesJob Description: Top Skills: · 2+ years of Document Control & Reporting Experience, · Veeva experience preferred · Technical troubleshooting · Self-motivated, independent, great communication · Experience working cross-functionally · Position Summary: · The Quality Assur ...
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QA Associate Specialist – Document Control
3 weeks ago
Pyramid Consulting, Inc Seattle, United StatesImmediate need for a talented QA Associate Specialist – Document Control. This is a 12+ Months Contract opportunity with long-term potential and is located in Seattle, WA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay ...
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TechDigital Seattle, United StatesPosition Summary: · The Quality Assurance Document Control ( QADC ) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and syst ...
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HonorVet Technologies Seattle, United StatesJob Description: Top Skills: · - 2+ years of Document Control & Reporting Experience, · - Veeva experience preferred · - Technical troubleshooting · - Self motivated, independent, great communication · - Experience working cross-functionally · Position Summary: · The Quality Assu ...
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On-Board Companies Seattle, United StatesOn-Board Services is hiring · Quality - QA Associate Specialist - Document Control · in Seattle, 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 on-si ...
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Omni Inclusive Seattle, United StatesTop Skills: · - 2+ years of Document Control & Reporting Experience, · - Veeva experience preferred · - Technical troubleshooting · - Self motivated, independent, great communication · - Experience working cross-functionally · Position Summary: · The Quality Assurance Docu ...
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Eclaro Seattle, United StatesQA Associate Specialist - Document Control · Job Number: · Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate Specialist - Document Control for our client in Seattle, WA. · Eclaro's client is a leader in the Biopharmaceu ...
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Primary Talent Partners, Inc. Seattle, United StatesPrimary Talent Partners is seeking a DOCUMENT CONTROL SPECIALIST to join our client's team in Seattle, WA. This role will be a 12-month, full-time contract role with a high potential for extension and/or conversion. · YOU MUST BE AUTHORIZED TO WORK IN THE US. · THIS IS FOR A W- ...
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Seattle Children's Seattle, United StatesResponsibilities: · The GMP Quality Assurance Document Control (QADC) Specialist will primarily be responsible for the Therapeutic Cell Production Core GMP Document Control operations, including the document change control process, issuance and reconciliation of batch records, b ...
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Document Control Administrator
3 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
2 weeks 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
3 weeks 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 Specialist
2 weeks 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 weeks 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 ...
Quality Assurance Document Control - Seattle, United States - Rangam
Description
Pay Scale: $36.00 to $38.00 per Hourly
Job Description:
Top Skills:
Position Summary:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
Duties/Responsibilities:
Primary responsibilities include:
Education: Bachelor's degree or equivalent
Experience Basic Qualifications:
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