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Quality Assurance Specialist
2 weeks ago
SSi People Bothell, United StatesRole: Quality Assurance Specialist · Location: Bothell, WA (Onsite) · Contract: 6 Months · Top Skills: · years of GMP work experience · with Batch Records · Experience Preferred · or BA Degree preferred, or HS Diploma + relevant work experience · skills include- strong cross-fun ...
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Specialist, Quality Assurance Operations
1 week ago
Yoh Bothell, WA, United StatesQA Floor Specialist · 6 month W2 contract (with potential to extend or transition to perm) · Pay rate: $38-42hour - Depending on Education and Experience · The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manuf ...
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PSG Global Solutions Bothell, United StatesAt Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of Specialist, Quality Assurance, Senio ...
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PSG Global Solutions Bothell, United StatesAt Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of Investigator, Quality Assurance, Spe ...
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Bristol Myers Squibb Bothell, United StatesWorking 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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Quality Assurance Specialist
1 week ago
Aequor Seattle, United StatesQA Associate Specialist – Document Control – · Seattle, WA 98109 · Duration: 12 months with possible extension · Pay rate: $37.36/hr. on W2 · Job Description: Top Skills: · 2+ years of Document Control & Reporting Experience, · Veeva experience preferred · Technical troubleshoot ...
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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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Quality Assurance Specialist
5 days ago
Defense Contract Management Agency Everett, United States Full timeDesigns/implements/maintains a risk-based surveillance program and assessment plan associated with the quality assurance provisions of contracts. · Identifies opportunities for process improvements by analyzing data. · As a member of a multi-functional or technical team, implemen ...
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Quality Assurance
1 week ago
Spectraforce Technologies Inc Bothell, United StatesTitle: Quality Assurance Specialist (Pharma ONLY - NON IT JOB) · Duration: 06 Months · Location: Bothell, WA · *Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · - 3-5 years of GMP work experience · - Familiarity with Batch Records · - Deviations Experience Preferre ...
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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 Shop Floor Specialist
2 weeks ago
Sunrise System inc 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 inclu ...
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QA Document Control Specialist
14 hours 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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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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QA Shop Floor Specialist
6 days ago
Sunrise System inc Bothell, United States**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- strong cross- ...
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Compliance Specialist II
1 week ago
Verathon Bothell, United StatesCompany Overview · Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted pati ...
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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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QA Shop floor Specialist
1 week ago
Sunrise Systems, Inc. Bothell, United StatesSunrise System Inc. is currently looking for QA Shop floor Specialist in Bothell, WA, Onsite with one of our top client. · Job Title: QA Shop floor Specialist · Location:Bothell, WA, Onsite · Duration: 6+ months · Position Type: Hourly contract Position (W2 only) · Job Descript ...
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QA Shop Floor Specialist
1 week ago
Aequor Bothell, United StatesPosition: QA Shop Floor Specialist · Location: Bothell WA 98021 · Duration: 6 months (possibility of extension for the right candidate depending on performance) · Pay rate: $42.41/ hour on W2 · **Schedule- 9:00 pm - 7:30 am, Sun-Wed** · **Top Skills: · 3-5 years of GMP work expe ...
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Quality GMP Specialist
1 week ago
Signature Consultants Bothell, United States Full timeTitle - Quality GMP Specialist · Duration- 06 months · Location- Bothell, WA · Pay range- $40.00 to $42.40/hr · **Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · - 3-5 years of GMP work experience · - Familiarity with Batch Records · - Deviations Experience Preferred · - ...
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QA Document Control Labeling Specialist
1 week ago
Fortira Inc Bothell, United States*Position Details:* · *Job Title: QA Document Control Labeling Specialist* · *Location: th Ave. SE, Bothell, WA, 98021* · *Duration: 6 Months Contract* · *Job Description:* · *Job Title: Quality Assurance Document Control (QADC) Associate Specialist* · *Location: Bothell, WA\*Ons ...
Quality Assurance Specialist - Bothell, United States - Axelon Services Corporation
Description
This is W2 contract NO c2c/Corp to corp
Pay range: $40 to $44 per hour on W2
Job 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- strong cross-functional experience, strong interpersonal skills
*Job Description:
The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports Jump's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at Jump with an emphasis on supporting Manufacturing with a Quality on-the-floor presence within a regulated cGMP environment.
The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at Jump by ensuring documentation is complete, accurate and that batch records are executed in accordance with approved and effective standard operating procedures and specifications.
The QA Specialist primary role is on-the-floor and contributes with off-the-floor projects and activities that are just as significant as on-the-floor work.
*Education:
Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.
3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
Hands-on experience with batch record review and product disposition is preferred.
Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection auditing, QA reporting, and approval of GMP documentation.
Strong computer skills with Word and Excel and other electronic manufacturing systems.
Detail oriented team player with effective planning, organization, time management and execution skills.
Proven experience working on teams where combined contribution, collaboration, and results were expected.
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Ability to work in a high paced team environment.
Strong written and verbal skills.
*ROLES AND RESPONSIBILITIES:
Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
Provide Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP.
Provides technical knowledge and guidance towards GMP compliance during triage/troubleshooting activities.
Review deviations, product non-conformities, and GMP investigations to ensure compliant resolution and adherence to current Good Manufacturing Practices (cGMPs).
Own, review, and approve deviations, including Deviation classification and completion of Impact Assessments, as applicable.
Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
Oversee manufacturing operations from patient material receipt to drug product pack out.
May support internal and external audits, including documenting observations.
Own and participate in review and approval for CAPAs.
Identify and facilitate continuous improvement projects.
Revise Standard operating Procedures as needed, and review/approve document revisions.
Drives right first time (RFT) by providing direct training, guidance, and problem solving to peers.
Provide training, coaching, and feedback for GMP guidance.
Continue support of continuous improvement culture and operational excellence methodologies.
Support change control initiatives as applicable.
Additional Job Requirements:
Lab w/ blood & animal
