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Quality Assurance
1 week ago
Global Pharma Woburn, United States**Title: Quality Assurance** · **Location: Woburn, MA** · **Duration: 09 Months** · Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform which ...
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Quality Assurance Specialist
2 weeks ago
Element Materials Technology Acton, United StatesOverview: · Element Materials Technology Boston-Acton, Inc. is looking for a full-time **Quality Assurance Specialist** to support the Quality Assurance Unit in a cGMP Microbiology Laboratory · **Responsibilities**: · - Comply with current Good Manufacturing Practice regulations, ...
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Quality Assurance Specialist
2 weeks ago
Axiomtek Methuen, United States**JOB BRIEF** · The position QA Specialist manages and maintains the database for the quality management system, prepares and presents quality trending reports, provides input to QA Manager and/or Team Leader on team member performance, maintains quality assurance documents and c ...
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Quality Assurance Specialist
1 week ago
The Arc of Opportunity Fitchburg, United StatesProvides administrative and clerical support for quality assurance functions by preparing reports and other necessary information. Supports the electronic file management system (iCentrix) system for all individuals served. Acts as the primary person responsible for day-to-day ma ...
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Quality Assurance Specialist
3 weeks ago
DPS Group Boston, United StatesADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...
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Quality Assurance Specialist
3 weeks ago
DPS Group TSO Boston, United States**Summary** · ADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk asses ...
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Quality Assurance Manager
3 weeks ago
DV Die Cutting Inc. Danvers, United States**Overview**: · **Duties**: · - Develop and implement quality assurance policies and procedures · - Maintain ISO documentation · - Conduct regular quality audits to identify areas for improvement · - Oversee quality control processes, including QA/QC inspections · - Collaborate w ...
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Quality Assurance Coordinator
3 weeks ago
MES Solutions, Inc. Norwood, United StatesOverview: · Are you a Medical Scribe who prides yourself on your strong writing/grammar abilities? Are you also looking to step away from a medical office and into a work-from-home position? · If you answered yes, then this might be the job for you because **MES **is looking for ...
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Quality Assurance Technician
3 weeks ago
Ultra Electronics Braintree, United StatesUnleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies. · Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldw ...
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Quality Assurance Specialist
1 week ago
Deephealth Somerville, United States**Job Description**: · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is _Leading Radiology Forward_. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNet's succ ...
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Manager, Quality Assurance Operations
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ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
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Functional Quality Assurance Manager
1 week ago
Lockheed Martin Chelmsford, United States**Job ID**: 661173BR · **Date posted**: Feb. 15, 2024 · **Program**: Functional · **Description**:Lockheed Martin is seeking to hire a Functional Quality Assurance Manager for the Chelmsford, MA facility. Responsible for overseeing processes and leading direct-report team members ...
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Director, Quality Assurance
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Ultragenyx Pharmaceutical Bedford, United States???? **Privacy Notice** · **Director, Quality Assurance (Warehouse Operations)** · Bedford, MA / Ultragenyx UGT Project Vector QA / Full-time *Be a hero for our rare disease patients* At Ultragenyx, we fundamentally believe that taking real impactful action to care for the need ...
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Director, Quality Assurance
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Ultragenyx Pharmaceutical Bedford, United States???? · **Privacy Notice** · **Director, Quality Assurance (Warehouse Operations)** · Bedford, MA / Ultragenyx · UGT Project Vector QA / Full-time · *Be a hero for our rare disease patients* · At Ultragenyx, we fundamentally believe that taking real impactful action to care fo ...
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Quality Assurance Lead
2 days ago
Elegant Enterprise Wide Solutions, Inc Boston, United States**Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...
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Quality Assurance Lead
4 days ago
Elegant Enterprise Wide Solutions, Inc Boston, United States**Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...
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Quality Assurance Manager
8 hours ago
RADcube Boston, United States**Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...
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IT Quality Assurance Analyst
1 week ago
EG America LLC Westborough, United States**Position Summary**:The IT QA Analyst is a supporting role to Application Management and Technology services efforts within the IT department. The IT QA Analyst will be responsible for the testing and certification of new releases of software to the existing production environme ...
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Specialist, Quality Assurance
2 days ago
Moderna Norwood, United States**The Role**: · The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc. · **Here's What You'll Do**: · Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or es ...
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Quality Assurance Test Manager
3 weeks ago
NavitsPartners Cambridge, United States**Position**: Quality Assurance Test Manager · **Duration**: 18-24 months · **Hours Per Week**: 37.5 · **Location**: Hybrid (Boston, MA) · **Position Summary**: · **Quality Assurance and Test Management**: · - Plan, execute, and lead testing efforts to ensure compliance with PROG ...
Manager, Clinical Quality Assurance - Bedford, United States - Lantheus
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden.For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.
Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands.
We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary of RoleResponsible for execution and performance of Lantheus CQA quality system elements including audit programs, inspection preparation support, continuous improvement, and quality system procedural documents.
Interface with internal and external customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.
Key Responsibilities/Essential functions:
Serve as the CQA lead for assigned trials and assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP/cGLP.Development and executionof a risk-based clinical quality audit plan for assigned programs.
Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and quality of scientific data.
Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement within pre-clinical/clinical development programs, vendors, and interfacing functional groups.
Evaluate adequacy and completeness of CAPA originated from audits, deviations, and/or inspections and perform effectiveness checks.Author audit reports and coordinate supporting documentation; manage same in QMS.Peer review reports authored by colleagues.
Identify non-compliance trends and systematic risks for assigned areas of responsibilityContribute to the development, maintenance, and continuous improvement of the quality system processes, tools, and E-SystemsSupportthe conduct of mock inspections and related activities; provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
Support Quality Management by facilitating regulatory agency inspections and related activities.Basic Qualifications:
BS degree in a scientific discipline and minimum of 7 years' experience in the pharmaceutical or biotech industry and a minimum of five (5) years in Clinical Quality Assurance.
Full understanding of ICH GCP and applicable CFR regulations with a working knowledge of cGLP.Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials.
Experience in conducting internal and external audits, authoring audit reports, managing CAPA process.Ability to manage processes with continuous improvement approach.
Analytical and critical thinking skills.
Experience developing SOPs and Work Instructions, reviewing internal clinical, regulatory, biometric, and medical processes to ensure they are accurately represented in current SOPs.
Oncology and/or medical imaging clinical development experience is a plus.Diplomatically work and collaborate at all levels within the organization with discretion.
Effective communication, planning, coordination, and time management skillsOther Requirements:
Up to 20% travel primarily in North America and CanadaRemote positionRequired to work on US East Coast time zone
Core Values:
The ideal candidate will embody Lantheus core values:Let people be their bestRespect one another and act as oneLearn, adapt, and winKnow someone's health is in our handsOwn the solution and make it happen#LI-HYBRID
