- 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.
- 2+ years of Document Control & Reporting Experience,
- Veeva experience preferred
- Technical troubleshooting
- Self motivated, independent, great communication
- Experience working crossfunctionally
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QA Document Control
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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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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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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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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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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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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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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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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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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 ...
Quality - QA Associate Specialist - Document Control - Seattle, United States - On-Board Companies
Description
On-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-site contract service provider for a local manufacturing entity providing full time positions to our employees.
We offer benefits as well as 401k.Position Details:
Position Type:
Quality - QA Associate Specialist - Document Control
Job Location:
Seattle, WA
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation:
$ /hourly (based on experience)
Duration: 12- month
Description:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the BMS Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
Responsibilities:
Qualifications:
Education:
Bachelor's degree or equivalent
Top Skills:
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry.
Today, On-Board is a thriving privately held family of companies with services including:
Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner.
"On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
JD#