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Quality Assurance
1 week ago
Harrison Publishing House Littleton, United StatesHPH is seeking a quality assurance analyst to review and correct product information. Attention to detail is very important. Must have a high school diploma or equivalent. Must work well with others, have basic computer skills, and experience with Microsoft Excel. · **Job Summary ...
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Quality Assurance
1 week ago
BlueWave Solutions Thornton, United StatesPassion for software quality? Join our team as a Quality Assurance / Test Automation Engineer (w|m|d) · In our modern and agile in-house full stack IT, you will develop automated test cases for new and existing features, applications, and releases of our software products. · You ...
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Director, Quality Assurance
1 week ago
Merck Sharp & Dohme West Point, United StatesWe are seeking an exceptional scientific leader for the role of Director, Quality Assurance in the Biologics/Vaccine Development Quality group, located in West Point, PA. · Biologics/Vaccine Development Quality (BVDQ) within Global Development Quality is responsible for technical ...
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Supervisor, Quality Assurance
1 week ago
AGC Boulder, United StatesSupervisor, Quality Assurance page is loaded · Supervisor, Quality Assurance · Apply · locations · Boulder, Colorado, USA · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · JR100386 · Our purpose is to bring hope to life by enabling life-cha ...
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Quality Assurance Employee
1 week ago
Spectrum Industries West Point, United States"REMONDIS PET Recycling GmbH is one of the most experienced and largest PET plastic recyclers in Germany, with around 15 years of experience. We serve customers throughout Europe with high-quality PET recycling plastics. In pursuit of a sustainable future, we work together with o ...
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Quality Assurance Management
1 week ago
Omega Ventures Milliken, United StatesMotivated individuals are the key to our success: That's why we are looking for a dedicated and passionate individual to join us as a Quality Assurance Manager (m/f/d) in part-time or full-time, to open a new chapter in our success story. · QUALITY ASSURANCE MANAGER (M/F/D) Traun ...
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Quality Assurance and Safety Manager
2 weeks ago
Vidya Brands Group LLC Westminster, United StatesSeaboard Folding Box is a full-service provider of custom structural packaging with extensive design, pre-press, printing and finishing capabilities. Our company has a 60+ year track record making folding cartons, and our highly experienced workforce allows us to deliver quick tu ...
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Software Quality Assurance Analyst
1 week ago
Knewin Boulder, United StatesTitle: · Software Quality Assurance Analyst · @ · Boulder , CO , · Terms of Hire: Full Time. · Salary: · $90,000–$100,000/yr + Benefits. (NO RELO) · Job description · Software Quality Assurance Analyst II · Client and Technologies Corp. is currently looking for a Software Qu ...
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Quality Assurance Technician Nights
3 weeks ago
BuildSubmarines Boulder, CO, United StatesWe are presently seeking a Quality Assurance Technician that will assure the expected outputs of the process are being met by qualifying the product to its specifications. · Qualify processes by conducting inspections to all geometric and surface quality tolerances · Use of cal ...
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Senior Manager, Quality Assurance
1 week ago
Foresight Dx Boulder, United StatesLocation: · On site or hybrid schedule in Boulder, Colorado, United States · About our Company: · Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients ...
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Quality Assurance Associate, II
1 week ago
AGC Biologics Boulder, United StatesOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to mark ...
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Senior Manager, Quality Assurance
6 days ago
Foresight Diagnostics Boulder, United StatesLocation: On site or hybrid schedule in Boulder, Colorado, United States · About our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worl ...
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Quality Assurance
1 day ago
Izzio Artisan Bakery LLC Louisville, United StatesJob Description · Job DescriptionDescription:Job Description · Izzio Artisan Bakery is a fast-growing artisan bread bakery focused on providing our customers with great breads created using traditional methods and the best possible ingredients. Our people are a major part of our ...
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Working student Quality Assurance
2 weeks ago
Stellar Innovations Federal Heights, United StatesAbout Daikin Manufacturing Germany GmbH: · We are a leading manufacturer of air conditioning and ventilation systems, heat pumps, and refrigeration technology. With over 90 years of experience in the development and production of heating and cooling solutions, we are now the mar ...
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Jr. Hardware Quality Assurance Engineer
3 days ago
Stem Boulder, United StatesStem provides clean energy solutions and services designed to maximize the economic, environmental, and resiliency value of energy assets and portfolios. Stem's leading AI-driven enterprise software platform, Athena, enables organizations to deploy and unlock value from clean ene ...
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Sr Quality Engineer- Design Assurance
2 weeks ago
Danaher Corporation Boulder, United StatesIntegrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart de ...
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Sr Quality Engineer- Design Assurance
4 weeks ago
Danaher Boulder, United States Full timeIntegrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart de ...
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Quality Assurance
1 week ago
Micron Memory Malaysia Sdn Bhd Longmont, United StatesOur vision is to transform how the world uses information to enrich life for · all . · Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate an ...
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Quality Assurance Manager
4 days ago
RISHAAR LLC Louisville, United StatesRoles & Responsibilities · Quality & Regulatory · Lead, Coach & Mentor team members for Quality, Regulatory & EHS functions. · Contribute to the creation and implementation of best practices for Quality: vision, strategy, · policies, processes, and procedures to aid and improve o ...
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Edgewise Therapeutics Boulder, CO, United StatesAbout Edgewise Therapeutics: · At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific preci ...
Senior Manager, Quality Assurance - Boulder, United States - Foresight Diagnostics
Description
Location:
On site or hybrid schedule in Boulder, Colorado, United StatesAbout our Company: Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide.
Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University.
Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients.
We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth.
Foresight Diagnostics is headquartered in Boulder, Colorado.About the Role:
The Senior Manager, Quality Assurance will be responsible for establishing and maintaining quality processes and improvement initiatives for FDA and ISO-regulated products and clinical testing, specifically supporting Foresight's GCP/CLIA laboratory.
This role will operationalize quality systems, leveraging your technical knowledge, skill and abilities to ensure regulatory compliance.The Senior Manager, Quality Assurance will also manage internal and external communication with regulatory agencies overseeing the clinical laboratory and ensuring all applications, systems, products and procedures meet defined quality standards.
This position will report to the Director of Quality.What You Will Bring:
Bachelor's degree in a scientific fieldMinimum of 7 years of experience in an FDA/ISO-regulated environment, including experience with Clinical regulations (CAP/CLIA/NYSDOH for high-complexity laboratory testing)
Ability to define, scope, map and implement new or improved documented quality processesKnowledge of BSL-2 laboratoriesExperience with LIMS, eQMS, and paper-based quality systemsExcellent verbal and written communication skills, as well as attention to detail and organizational skillsWhat You Will Do:
Implement and maintain the necessary programs to support the Quality Policy, the Quality System, and continuous improvement initiatives to ensure compliance with ISO15189, FDA GCP and GLP, CAP/CLIA, NYSDOH, and other US and international regulatory standards.
Ensure that Quality System elements are in compliance with Clinical, ISO, and FDA regulations, and help to create and/or drive improvements to Policies and Standard Operating Procedures.
Oversee FDA-regulated design control activities to ensure effective and compliant execution for the Foresight assay and software design.Manage design control documentation required for effective DHF/DHR/DMR management.
Organize and lead the management of NCR/CAPA, complaints, management review, laboratory support, services, processes, reporting, supplier management, document and records control, training, audits, and other QMS responsibilities.
Define and maintain quality metrics to measure, analyze, and implement processes to monitor and improve quality.Identify and evaluate issues and/or gaps in processes and documentation, and propose effective solutions to remediate.
Host and provide front-room representation during internal and external audits, including CAP, FDA, ISO, and biopharmaceutical companies.
Manage audit program, including schedule adherence, reviewing audit reports, and following up on required actions.
Maintain the eQMS and provide document control support.
TeamCommunicate and interact with all levels of the organization including Executive LeadershipWork effectively with cross-functional teams for problem-solving, product and process improvementCultivate, build and maintain positive and collaborative relationships within the Quality team and cross-functionallyOperate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific, and performance standards to ensure the highest quality for sample integrityLeverage leadership skills to motivate, inspire and train staff to engage in quality and adhere to regulationsThis role is offering a salary between $155,000-169,000 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is April 5, 2024You will be working on interesting problems with extremely high impact.
We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees.
Foresight Diagnostics is an equal opportunity employer.We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Senior Manager, Quality Assurance professionals in Boulder
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Dottie Stowe
Sales & Operations for Brands & Communities