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Quality Manager
4 weeks ago
The Fountain Group Framingham, United StatesCore Responsibilities include:Investigating and writing deviations, laboratory investigations, CAPAs, Tasks,Effectiveness reviews, and audit observation responses.Define and implement CAPAs, tasks, and effectiveness reviews with theassistance of QC ManagementManage / own CCRs and ...
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Quality and Regulatory Compliance Manager
5 days ago
Katalyst HealthCares & Life Sciences Framingham, United StatesResponsibilities: Ensure compliance with quality standards and regulatory requirements for products subcontracted to external entities, adhering to cGMPs and quality directives. · Oversee the efficiency of the Quality System implemented between the company and subcontractors, m ...
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Quality Manager V
4 weeks ago
PSG Global Solutions Framingham, United StatesWe're looking for a · Quality Manager V , working in · Pharmaceuticals · and · Medical Products · industry in · 31 New York Avenue, Framingham, Massachusetts, 01701, United States . · Participate in project teams involved in site biotech facilities, processes and equipment ...
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Quality Manager
1 day ago
Stanley Black & Decker Holliston, United StatesQuality Manager - Holliston, MA, United States- Onsite · Come build something that matters. · It takes great people to achieve greatness. People with a sense of purpose and integrity. People with a relentless pursuit of excellence. People who care about making things better For ...
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Quality Manager
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Stanley Black & Decker Holliston, United StatesQuality Manager - Holliston, MA, United States- OnsiteCome build something that matters. It takes great people to achieve greatness. People with a sense of purpose and integrity. People with a relentless pursuit of excellence. People who care about making things better For Those ...
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Quality Manager
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Stanley Black & Decker Holliston, United States Full timeQuality Manager - Holliston, MA, United States- Onsite · Come build something that matters. · It takes great people to achieve greatness. People with a sense of purpose and integrity. People with a relentless pursuit of excellence. People who care about making things better For ...
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Quality Management Manager
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SilverWorks Chelsea, United StatesThe Hydrotechnik GmbH is an innovative, owner-managed, medium-sized company and is one of the leading providers of industrial measurement technology for diagnosis and condition monitoring of high-pressure systems - nationally and internationally. With worldwide sales offices, the ...
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Quality Manager V
1 week ago
PSG Global Solutions Careers Framingham, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Manager V, working in Pharmaceuticals and Medical Products industry in 31 New York Avenue, Framingham, Massachusetts, 01701, United Sta ...
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Quality Manager V
1 week ago
PSG Global Solutions Careers Framingham, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Quality Manager V, working in Pharmaceuticals and Medical Products industry in 31 New York Avenue, Framingham, Massachusetts, 01701, U ...
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Manager, Trainee- Quality
4 weeks ago
Biolife Plasma Services Framingham, United StatesBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit ...
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Quality System Manager
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BlackTree Technical Group, Inc. Sudbury, United StatesQuality Systems Manager · SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: · • Manage QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, MDD/MDR, and individual country requirements). · • Manage Document Contro ...
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Quality Systems Manager
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Infinity Systems Institute, United StatesAbout the Company · Whether it's wiring systems, electromechanical systems, high-voltage or SCR systems: we stand for technology that serves progress and people. We know all about pole positions, for example when it comes to the mobility of tomorrow. Our goal: the winner's podium ...
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Quality Management System Manager
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Whitridge Associates Wayland, United StatesSUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES: · Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. · Key opinion leader for the oversight over manufacturing of ass ...
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Quality Manager
4 weeks ago
Gables Search Group Westborough, United StatesResponsibilities Understand customer needs and requirements to develop effective quality control processes Devise and review specifications for products or processes Set requirements for raw material or intermediate products for suppliers and monitor their compliance Ensure adher ...
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Quality Manager
4 weeks ago
International Staff Consulting Westborough, United StatesResponsibilitiesUnderstand customer needs and requirements to develop effective quality control processesDevise and review specifications for products or processesSet requirements for raw material or intermediate products for suppliers and monitor their complianceEnsure adherence ...
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Quality Manager
2 weeks ago
Bestlogic Staffing Westborough, United StatesAbout the job Quality Manager · Responsibilities · Understand customer needs and requirements to develop effective quality control processes · Devise and review specifications for products or processes · Set requirements for raw material or intermediate products for suppliers an ...
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Housing Quality and Safety Manager
4 weeks ago
Pine Street Inn Jamaica Plain, United StatesSCHEDULE: Monday - Friday, 8:00 AM to 4:30 PM · LOCATION: 82 Green Street, Jamaica Plain. This is a mobile position with extensive travel between housing sites in Metro Boston · JOB DESCRIPTION: · SUMMARY OF THE POSITION: · The Housing Quality and Safety Manager is responsible ...
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Housing Quality and Safety Manager
3 weeks ago
Pine Street Inn Jamaica Plain, United StatesHousing Quality and Safety Manager · Department: Supportive Housing - Property Management · Office: 82 Green Street · Location: Jamaica Plain, MA · Position Type: Direct Care · Hours/Shift: Morning - First Shift · Employee Type:: Regular Full-time · START YOUR APPLICATION ) · SCH ...
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Manager, Quality Systems
17 hours ago
Quest Diagnostics Marlborough, United StatesOverview: · Manage the quality management system and regulatory requirements for Quest Diagnostics to comply with all applicable regulations and standards including but not limited to FDA CFR Part 820 (QSR), ISO Quality Systems), ISO Risk Management), IVDR 2017/746 (In-Vitro Dia ...
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Quality Manager
2 weeks ago
Repligen Shrewsbury, United StatesManage the timely release of Incoming Inspection materials to maintain departmental goals. Ability to schedule activities to meet the priorities of Manufacturing requirements. Manages direct reports which includes, setting objectives, monitoring perf Manager, Quality, Area Manage ...
Quality Manager - Framingham, United States - The Fountain Group
Description
Core Responsibilities include:
Investigating and writing deviations, laboratory investigations, CAPAs, Tasks,
Effectiveness reviews, and audit observation responses.
Define and implement CAPAs, tasks, and effectiveness reviews with the
assistance of QC Management
Manage / own CCRs and liaise with functional QC units for work execution
Conduct self-inspection / audit walkthroughs
Support internal / external audits and participate in and / or lead the completion of
responses to internal / external audit related observations / CAPA
Conduct gap assessments against external and / or other Sanofi sites audit
observations and assist with plan development to drive remedial actions.
Maintain a high level of personal compliance to the required company standards
and industry best practices
Provide expertise during procedure / SOP revision process and function as DCR
approver for department related SOPs, where required
Partner with QC operations and manufacturing, where applicable, to support a
culture of continuous compliance / improvement
Assist in generating metrics at the required frequency to drive accountability and
delivery of targets
Requirements need to be quantifiable.
Bachelor's Degree in science or technical field 6 years' of experience in biopharmaceuticals or related industry working in a regulated, GMP environment
Or
Master's degree and a minimum of 3 years' experience working in a regulated, GMP environment.
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