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Quality Assurance
3 weeks ago
Radiant company Kenosha, United StatesPay Rate is $ 25/hr · Job Title: Quality Technician I · Work Location: Kenosha Distribution Center, th Ave. Kenosha, WI 53142 · Duration: 04/01/2024 to 12/01/2024 · Temp to Hire · 1st Shift: 6:00 AM - 2:30 PM · Must have at a minimum an Associates Degree · RESPONSIBILITIES · Work ...
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Quality assurance
5 hours ago
Randstad North Chicago, United Statesjob summary: · As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of ...
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Quality assurance
15 hours ago
Randstad North Chicago, United Statesjob summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of to ...
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Quality Assurance
3 days ago
Spectraforce Technologies North Chicago, United StatesDescribe the primary goals, objectives or functions or outputs of this position.Individual will work in AbbVie's Post Market QA organization investigating return samples for medical device and combination product complaints and inquiries. Responsible for product complaint documen ...
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Quality Assurance
2 days ago
Mindlance North Chicago, United StatesDescribe the primary goals, objectives or functions or outputs of this position. · Individual will work in s Post Market QA organization investigating return samples for medical device and combination product complaints and inquiries. Responsible for product complaint documentati ...
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Quality Assurance
2 days ago
The Fountain Group North Chicago, United StatesThe Fountain Group is a national staffing firm and we are currently seeking a QA Specialist I for a prominent client of ours. This position is in North Chicago, IL Details for the position are as follows: · Job Description: · $24 - $26/hour based on previous experience & ...
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Quality Assurance
1 week ago
The Fountain Group North Chicago, United StatesThe Fountain Group is currently seeking an Intake Specialist for a prominent client of ours. This position is located in North Chicago, IL. Details for the position are as follows: Job Description: $21.00-$22.00/HR to start 6-month onsite assignment length- (potential to extend/c ...
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Quality Assurance
1 week ago
Collins Consulting Waukegan, United StatesThis is a hybrid position. · Job Title: Product Complaint Analyst I · Candidates with Product Quality Complaint experience preferred and especially Device Complaint related experience. · Individual will work in the client's global quality organization processing pharmaceutical, m ...
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Quality Assurance
15 hours ago
US Tech Solutions Waukegan, United StatesDescribe the primary goals, objectives or functions or outputs of this position. Individual will work in Post Market QA organization investigating return samples for medical device and combination product complaints and inquiries. Responsible for product complaint documentation, ...
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Quality Assurance Supervisor
1 week ago
Panek Precision Northbrook, United StatesLarge Northbrook based automotive manufacturer specializing in CNC and multi-spindle precision machining is seeking a Quality Assurance Manager/Supervisor. · - Managing a Quality team · - Dealing with customer issues and complaints · - Developing and executing control plans and P ...
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Quality Assurance Supervisor
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LSG Sky Chefs Des Plaines, United StatesWe are seeking a passionate and experienced Quality Assurance Supervisor to join our team and play a vital role in upholding our commitment to excellence. In this leadership position, you will be responsible for overseeing all aspects of our quality assurance program, ensuring co ...
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Quality Assurance Technician
1 week ago
Outerwild Lake Zurich, United States**DESCRIPTION OF DUTIES AND RESPONSIBILITIES of Quality Assurance Technician**: · - Able to understand and use measuring equipment such as calipers, micrometers, gauging, etc. · - Perform detailed visual and dimensional inspection of tight tolerance production parts. · - Performs ...
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Quality Assurance Manager
3 weeks ago
QntmLogic, LLC. Schiller Park, United StatesIATF ISO9001:2000 certified contract metal stamping and manufacturing company, servicing a world-class customer base in the automotive, appliance, and consumer electronics marketplace, seeks an experienced and motivated Quality Systems & Assurance Manager. POSITION RESPONSIBILITI ...
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Quality Assurance Manager
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The Vegan Copacker Elk Grove Village, United States**Overview**:Seeking an experienced and motivated individual to join our team as a Quality Assurance Manager. As the Quality Assurance Manager, you will play a crucial role in maintaining and enhancing the quality of our food products. You will be responsible for developing, impl ...
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Quality Assurance Analyst
3 weeks ago
Uline Glenview, United States**Quality Assurance Analyst** · **Corporate Headquarters** · **12575 Uline Drive, Pleasant Prairie, WI 53158** · Unlock your full potential as a Quality Assurance Analyst at Uline Join a collaborative environment where you'll design, develop, and deliver custom solutions to big c ...
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Quality Assurance Manager
1 week ago
QntmLogic, LLC. Schiller Park, United StatesIATF ISO9001:2000 certified contract metal stamping and manufacturing company, servicing a world-class customer base in the automotive, appliance and consumer electronics marketplace, seeks an experienced and motivated Quality Systems & Assurance Manager.POSITION RESPONSIBILITIES ...
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Quality Assurance Representative
2 weeks ago
Speed Express Elk Grove Village, United States**Position Overview**: As a QA Representative for Exception Package Processing at SpeedX, you will play a vital role in maintaining the integrity and efficiency of our logistics operations. Working closely with both our operations team and customer service department, you will be ...
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Quality Assurance Associate
3 weeks ago
HelloFresh Lake Zurich, United StatesAt HelloFresh, we want to change the way people eat forever by offering our customers high-quality food and recipes for different meal occasions. Over the past 10 years, we've seen this mission spread around the world and beyond our wildest dreams. Now, we are a global food solut ...
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Quality Assurance Technician
2 weeks ago
Fresh Express Streamwood, United States**Food Safety Role & Responsibility**: · As an individual, the incumbent must understand the Food Safety Statement, complete the required training, perform work assignments in accordance with training and display an acceptable level of competency with all Quality Assurance/Safety ...
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Quality Assurance Specialist
3 weeks ago
Actalent Niles, United States Full timeDescription: · First Shift (Full Time) · Sample Inspection · Incoming Samples · Visual Inspection · Ability to lift 40 pounds · Documentation into software system · Batch Records · May be required to operate forklift · Responsible for: · Perform visual inspection of incoming mate ...
Senior Manager Quality Assurance - North Chicago, United States - AbbVie
Description
Job Description
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.
Responsible for quality of assigned products which includes combination products and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
Maintains the primary quality lead with management oversight for project Quality activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results.
Leads the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities.
Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management.
Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled.
Helps facilitate resolution in cases where they are not.
Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service.
Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.
Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
Manages Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing.
Supports the management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups (R&D, S&T, Site Tech Ops) to determine root cause and implement appropriate actions.
Develops product quality transfer process monitoring metrics. Manages small teams of quality professionals as required and maintains departmental spend within budget.
Supports the regulatory filings and marketing authorization dossiers by developing and/or reviewing of chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph.
Work with AbbVie Affiliates and Regulatory to prepare submissions and participate on emergency response team for all incoming submission deficiencies and questions.
