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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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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 day 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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Quality Assurance Document Control
1 day 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 Labeling Specialist
1 week ago
TSR Consulting Services, Inc. Bothell, United StatesOur client, an established pharmaceutical company is in search of a QA Document Control Labeling Specialist to join their team on a W2 contract. · Shift- Sunday - Thursday 10:00pm - 6:30am · Top Skills: · • Strong communication and customer service skills. · • Innovation · • Abl ...
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Document Controller
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The Bergaila Companies Marysville, United StatesOverview · We are seeking a Document Controller for assignment in Marysville, Ohio. The selected candidate will be responsible for digitizing, maintaining and retrieving company records as required. · Hours are Monday - Friday, 8:00am - 4:30pm · ** This position has a pay rate ...
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Document Control Specialist II
3 weeks ago
Verathon Bothell, United StatesVerathon, Inc. · Document Control Specialist II · Bothell , · Washington · Apply Now · Document Control Specialist IILocationUS-BothellID CategoryQuality Assurance/Regulatory AffairsPosition TypeFull-TimeWork ModelOnsiteCompany OverviewVerathon is a global medical device com ...
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Quality Assurance Document Control
2 weeks ago
On-Board Companies Bothell, United States· On-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 ...
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Quality Assurance Document Control
3 weeks ago
On-Board Companies Bothell, United StatesOn-Board Services is hiring aQuality Assurance Document Control (QADC) Associate Specialistin Bothell, WA · For immediate consideration please send your resume to .comSubject Line: Position Title and State you are Located. · About Us:On-Board Services, Incorporated is an on-sit ...
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Document Control
1 week ago
Safran Marysville, United StatesDocument Control & Training Administrator - SCM MV · Company : · Safran Cabin Materials · Job field : Administrative · Location : Marysville , Washington , United States · Contract type : Permanent · Contract duration : Full-time · Required degree : High School Diploma/GED ...
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Quality Assurance Document Control
3 weeks ago
Pyramid Consulting 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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QA Document Control Labelling Specialist
2 weeks ago
Integrated Resources Bothell, United StatesJob Title: QA Document Control Labelling Specialist · Location: Bothell, WA · Duration: 6 months+ · Pay Rate: $56.53/Hr On W2 · Shift- Sunday - Thursday 10:00PM - 6:30AM · Top Skills: · Strong communication and customer service skills. · Innovation · Able to prioritize, m ...
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Scientist, Document Control
1 day ago
Axelon Services Corporation Seattle, WA, United Statesexperience working with Waters UPLC system and Empower software · - Methods: SEC-U/HPLC, SEC-MALS, IEX, RP-LC, Affinity, CE: PA800 (SCIEX) CE-SDS, CZE, cIEF · - Cell Therapy Product and Analytical Development (P&AD) is seeking an enthusiastic, self-driven Scientist to join its ...
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Bristol Myers Squibb Bothell, United States OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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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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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, batc ...
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Integrated Resources, Inc ( IRI ) Bothell, United StatesJob Description: **Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · Associates or BA Degree preferred, or HS Diploma + relevant work experience · Soft skills include- str ...
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QA Shop Floor Specialist
4 weeks ago
Integrated Resources, Inc ( IRI ) Bothell, United StatesTitle: QA Shop Floor Specialist · Location: Bothell, WA · Duration: 12 months · Shift: 9 PM to 7:30 AM PST Wed to Sat. · Skills: 1–3-year GMP exp, 1-3 batch record, clean room, or other controlled spaces. Also consider fresh grad. · Familiarity with Batch Records · Deviations Exp ...
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Engineering Technician
3 weeks ago
Career Management Group Bothell, United StatesCareer Management Group is looking for an experienced Engineering Technician to support the Supplier Quality & Manufacturing Quality teams and complete essential quality activities. · The ideal candidate will be organized, multifaceted, with experience in both Supplier Quality & ...
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Project Engineer II
3 weeks ago
ISEC Bothell, United StatesProject Engineer II · Bothell, WA, USA Req #125 Thursday, April 25, 2024 Reports to: Operations Manager/Project Manager · FLSA Status: Exempt · Position Summary · The Project Engineer is responsible for assisting the Project Manager with administrative duties associated wi ...
Quality Assurance Document Control - Bothell, United States - LanceSoft
Description
Job 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-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
Job Description:
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
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.
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 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.
Weekend and off-shift support may be required.
