Current jobs related to QMS Solutions Lead Specialist - Billerica, Massachusetts - Lantheus

  • IT Manager

    1 month ago

    Billerica, Massachusetts, United States LS Solutions Full time

    Job Title: IT Manager – QMS Systems Development, PolarionLS Solutions is seeking an experienced IT Manager to lead the development of Quality Management Systems (QMS) using Polarion. The ideal candidate will have a strong background in IT, Polarion technical expertise, and experience working in the Medical Device or Pharmaceutical industry.Key...

  • Quality Assurance Specialist

    1 week ago

    Billerica, Massachusetts, United States Quanterix Full time

    At Quanterix, we are seeking a highly motivated Quality Assurance Specialist to join our Accelerator Laboratory in Billerica, MA.The successful candidate will be responsible for quality review of documents for IVD products and compliance with the QMS.This role will support vendor qualification, audits, complaints, and investigations within the Quanterix...

  • Quality Assurance Specialist

    2 weeks ago

    Billerica, Massachusetts, United States Nuclera Full time

    About NucleraNuclera is a pioneering biotech company that has revolutionized the field of protein expression and purification. Our cutting-edge eProtein DiscoveryTM System makes proteins accessible to life science researchers, accelerating breakthroughs in human health.Quality Engineer RoleWe are seeking a highly skilled Quality Engineer to join our Quality...

  • Quality Assurance Specialist

    3 weeks ago

    Billerica, Massachusetts, United States Nuclera Full time

    About NucleraNuclera is a pioneering biotech company headquartered in Cambridge, UK, with significant operations in Boston, USA. Our company is at the forefront of bringing rapid protein expression and purification screens to the benchtop, making proteins accessible through the eProtein DiscoveryTM System.We accelerate breakthrough improvements in human...

  • Quality Assurance Specialist II

    1 month ago

    Billerica, Massachusetts, United States Quanterix Full time

    Quality Assurance SpecialistQuanterix is a leading company in the field of biomarker analysis, aiming to advance the science of precision health. Our ultra-sensitive detection solution, Ssimoa, has the potential to revolutionize the way healthcare is provided today. We are seeking an experienced and highly motivated Quality Assurance Specialist to join our...

  • Associate Quality Control Compliance Specialist

    2 weeks ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryAs a key member of our quality control team, the Associate Quality Control Compliance Specialist will play a critical role in ensuring the quality and compliance of our products. This is a unique opportunity to join a dynamic team and contribute to the success of our organization.The Associate Quality Control Compliance Specialist will be...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Medtronic Full time

    About the RoleWe are seeking a skilled Quality Technician III to join our quality assurance team in Billerica, MA. In this role, you will be responsible for creating and maintaining documentation systems that ensure our products meet the highest standards of quality and compliance.Key ResponsibilitiesPerform reviews of paper production records to ensure...

  • Quality Assurance Specialist II

    1 week ago

    Billerica, Massachusetts, United States Quanterix Full time

    Quality Assurance Specialist II Job DescriptionAbout the Role:We are seeking an experienced Quality Assurance Specialist II to join our team at Quanterix. The successful candidate will be responsible for ensuring the quality and compliance of our products and services.Key Responsibilities:* Establish and maintain a culture of trust and compliance with...

  • Pharmaceutical Delivery Specialist

    2 weeks ago

    Billerica, Massachusetts, United States Strategic Delivery Solutions, LLC Full time

    Job Summary: Strategic Delivery Solutions, LLC is seeking a skilled Pharmaceutical Delivery Specialist to join our team. As a Medical Courier, you will be responsible for delivering time-sensitive medications to hospital facilities throughout the metro area and surrounding cities/states.Key Responsibilities:* Deliver medications to hospital facilities in a...

  • Quality Assurance Manager

    3 weeks ago

    Billerica, Massachusetts, United States Access Vascular Inc Full time

    Quality Manager Job Description **Job Summary:** We are seeking a highly skilled Quality Manager to oversee our Quality Management System (QMS), handle customer complaints, manage return goods, oversee post-market surveillance, coordinate Corrective and Preventive Actions (CAPAs), and lead training initiatives. **Key Responsibilities:** * Develop,...

  • Manufacturing Engineering Specialist

    1 week ago

    Billerica, Massachusetts, United States Spark Life Solutions, Inc. Full time

    Key Responsibilities:As a Manufacturing Engineering Specialist at Spark Life Solutions, Inc., you will be responsible for ensuring the development and optimization of manufacturing equipment and tooling. This includes process validation, layout modeling, and documentation. Additionally, you will be involved in equipment and tooling development, process...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Medtronic Full time

    Quality Technician III Job DescriptionAt Medtronic, we're committed to delivering innovative healthcare solutions that improve lives. As a Quality Technician III, you'll play a critical role in ensuring our products meet the highest standards of quality and compliance.Responsibilities:Perform reviews of paper production records to ensure compliance with...

  • Associate, QC Compliance Specialist

    2 weeks ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Quality Control Compliance Associate role is a dual-function position that combines QC compliance activities with QC laboratory GMP testing activities. The successful candidate will perform various quality control tests on raw materials, in-process, and final products using approved test methods, Standard Operating Procedures (SOPs), and work...

  • Associate, QC Compliance Specialist

    1 week ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries Inc. Full time

    Job SummaryThe Associate Quality Control - Compliance role is a dual function position at Sun Pharmaceutical Industries Inc. The role is divided between QC compliance activities and QC laboratory GMP testing activities. Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating...

  • IT Support Specialist

    1 week ago

    Billerica, Massachusetts, United States Merge IT LLC Full time

    Job Title: IT Support SpecialistJob Summary:We are seeking an IT Support Specialist to join our team at Merge IT LLC. As an IT Support Specialist, you will be responsible for providing technical support to our clients, troubleshooting issues, and ensuring that our clients' IT systems are running smoothly.Responsibilities:Provide technical support to clients...

  • Associate, Quality Control Specialist

    3 weeks ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Associate Quality Control - Compliance role is a dual function position that combines quality control compliance activities with laboratory GMP testing. The successful candidate will perform various quality control tests on raw materials, in-process, and final products using approved test methods, Standard Operating Procedures (SOPs), and...

  • Associate, Quality Control Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Sun Pharma Full time

    Job SummaryThe Associate Quality Control - Compliance role is a dual function position that combines quality control compliance activities with laboratory GMP testing. The successful candidate will perform various quality control tests on raw materials, in-process, and final products using approved test methods and Standard Operating Procedures (SOPs). They...

  • Quality Assurance Specialist

    4 weeks ago

    Billerica, Massachusetts, United States Medtronic Full time

    About the RoleMedtronic is seeking a highly skilled Quality Technician III to join our quality assurance team in Billerica, MA. In this role, you will be responsible for creating and maintaining documentation systems that ensure our products meet the highest standards of quality and compliance.Key ResponsibilitiesPerform review of paper production records to...

  • Associate, QC Compliance Specialist

    1 week ago

    Billerica, Massachusetts, United States Sun Pharmaceutical Industries, Inc. Full time

    Job DescriptionJob SummaryThe Associate Quality Control - Compliance role is a dual function position that combines quality control compliance activities with laboratory GMP testing. The successful candidate will perform various quality control tests on raw materials, in-process, and final products using approved test methods, Standard Operating Procedures...

  • Director of Safety Solutions and Account Management

    1 week ago

    Billerica, Massachusetts, United States PAREXEL Full time

    Job Summary:The Director of Safety Solutions and Account Management will be responsible for developing and implementing client safety solutions in a Clinical Research Organization environment. This includes experience in developing bids and proposals, client-facing experience with related skills, and knowledge of process improvement, including the role of...

QMS Solutions Lead Specialist

2 months ago

Billerica, Massachusetts, United States Lantheus Full time

Company Overview
Lantheus is a leading organization in the medical imaging sector, dedicated to enhancing patient care through innovative diagnostics and therapeutic solutions. With a global presence, Lantheus has been at the forefront of the industry for over six decades.

Position Summary
We are seeking a dynamic and experienced Business Analyst to join our Quality Systems team. This role is pivotal in supporting our Quality business community by executing requirements and collaborating with technical teams to deliver effective Quality technical solutions.

Key Responsibilities
- Gather, develop, and document functional and user business requirements.
- Transform user needs into functional specifications.
- Possess a strong understanding of LIMS solutions, preferably LabVantage.
- Integrate LIMS with Empower CDS.
- Administer at least one QMS Solution such as AsurX, TrackWise, Veeva, or MasterControl.
- Manage at least one CDS system, with a preference for Empower.
- Oversee IT setup, troubleshooting, and maintenance of laboratory equipment and software.

Collaboration and Compliance
- Work closely with Project Managers to address issues, concerns, and delivery schedules.
- Experience in a GxP validated environment, contributing to validation documents like IQ and OQ.

Qualifications
- BA/BS degree in Information Technology or Computer Science with over 5 years of relevant experience.
- Preferred experience in Quality Controls, Quality Systems & Document Management, and Computer Systems Validation.
- Strong understanding of Computer Systems Validation and Software Life Cycle Management.
- Excellent written and verbal communication skills, with a collaborative approach across multiple functions.

Additional Requirements
- Willingness to travel overnight as required by business needs.