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Amazon
North Reading, MA, United States
Description We are working on the future. If you are seeking an iterative fast-paced environment where you can drive innovation, apply state-of-the-art technologies to solve extreme-scale real world challenges, and provide visible benefit to end-users, this is your opportunity. Come work on the Amazon Robotics – Mechatronics & Sustainable Packagin
Job Source: AmazonWalmart Advanced Systems and Robotics
Andover
Job Description Job Description Walmart Advanced Systems & Robotics is a rapidly expanding initiative with the objective of revolutionizing the retail landscape through robotics. Our development and implementation of the cutting-edge Alphabot® technology are currently underway, with deployment in stores across North America. The Quality Assuranc
Job Source: Walmart Advanced Systems and RoboticsAmazon
North Reading
Description We are working on the future. If you are seeking an iterative fast-paced environment where you can drive innovation, apply state-of-the-art technologies to solve extreme-scale real world challenges, and provide visible benefit to end-users, this is your opportunity. Come work on the Amazon Robotics – Mechatronics & Sustainable Packaging
Job Source: AmazonGalaxyinfotechinc
Tyngsborough, MA, United States
SUMMARY : The Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's products, processes, and services. Responsibilities Oversee the company's adherence to domestic and international regulatory standards, including FDA regulations, ISO standards, ASTM, and Euro
Job Source: GalaxyinfotechincComprehensive Staffing Solutions of Georgia
Tyngsborough, MA, United States
Job Description The Quality Assurance Manager will be responsible for managing the quality management system and ensuring regulatory compliance for the company's products, processes, and services. Oversee the company's adherence to domestic and international regulatory standards, including FDA regulations, ISO standards, ASTM, and European Medical
Job Source: Comprehensive Staffing Solutions of GeorgiaPhilips North America
Cambridge, MA, United States
Job TitleQMS Software Validation Engineer Job Description Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all. In this role you have the opportunity to Support pro
Job Source: Philips North AmericaPhilips
Cambridge, MA, United States
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all. In this role you have the opportunity to Support project teams by providing awareness, guidance and feedback
Job Source: PhilipsXybion Corporation
Boston
Job Description Job Description About Us Serving more than 350 customers in 35+ countries, Xybion (TSXV:XYBN) has the global scale and expertise to bring employees around the world together to drive digital transformation of laboratories. Xybion is a leading ai enabled software as a service company dedicated to helping corporations solve business
Job Source: Xybion CorporationBillerica, MA, United States
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 have helped physicians enhance patient care with our 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. Lantheus is in search of an innovative, transformative, high-energy, experienced Business Analyst for our Quality Systems team.
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 skills sets to be a part of a productive and inclusive team.
This individual will support the Quality business community executing requirements and coordinating with the technical community, IT project teams and business clients for Quality technical solutions including QMS, CDS, QC RDS, LIMS, NuGenesis ALM, etc. This role will work with the business to define functional business requirements and help develop, execute, deploy, and support the current Quality technical solutions and play a key role implementing new solutions supporting the Lantheus Digital Strategy.
Key Responsibilities/Essential Functions
Gather, develop, clarify and document functional/user business requirements
Transform the users’ requirements into functional requirements
Strong understanding of LIMS solutions (LabVantage preferred)
Knowledge of integrating LIMS with Empower CDS
Experience with the administration of at least one QMS Solution (AsurX, TrackWise, Veeva, MasterControl, etc.)
Experience with the administration at least one CDS systems (Empower preferred)
Experience with IT setup, troubleshooting, back-up, upgrades, & decommissioning lab equipment/software such as HPLC, GC, AA, UV/FTIR/Raman, titrators, endotoxins, total particulates, balances, pH meters, etc.
Ability to collaborate with Project Managers on issues, concerns, schedules of deliveries and completion estimates
Experience working in GxP validated environment and have contributed to the creation and execution of validation documents such as IQ and OQ
Skills And Experience And Education
BA/BS degree in Information Technology or Computer Science with 5+ years progressive experience in data integration
Experience in the following areas preferred: Quality Controls within Manufacturing, Quality Systems & Document Management, Quality Assurance, Computer Systems Validation, GxP, Validated Change Control and Product Life Cycle Management
Understanding of Computer Systems Validation and the full Software Life Cycle management
Strong written and verbal communication skills
Strong collaboration skills with the ability to work in a team dynamic across multiple functional organizations
Experience in the life science industry or like industry essential
Demonstrated analytical, troubleshooting, and problem-solving skills
Other Requirements
Non-routine overnight travel based on business need.
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Email Alert for QMS Systems Lead jobs in Billerica, MA, United States
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