FDA Jobs in Massachusetts

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Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 1 day ago | Updated 3 hours ago

Regulatory affairs - CMC Manager

Sureminds Solutions

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Remote

Contract

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product su
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Posted 14 days ago

Engineer, Quality

Experis

•

Westford, Massachusetts, USA

Full-time

Title: Engineer, Quality Location: Westford, MA (Onsite) Duration: 6 Months Pay Range : $40 /hr to $46 /hr (On W2) We are looking for a "Engineer, Quality" to join one of our Fortune 500 clients. Job Summary: The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analys
Posted 1 day ago | Updated moments ago

SAP Genealogy Lead

Intento Analytics LLC

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Remote

Contract

Job title: SAP Genealogy Lead Remote Core Functional SkillsProduct Genealogy Knowledge: Deep understanding of batch traceability, serial number tracking, and material flow. Expertise in forward and backward tracing of components, semi-finished, and finished goods. SAP Modules Expertise: SAP ME / MII / DM (for discrete and process manufacturing). SAP PP / PP-PI (Process Industries), QM, EWM, and MM. Batch Management configuration in SAP ECC or S/4HANA. Integration with SAP ATTP (for pharmaceutica
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Posted 3 hours ago | Updated 3 hours ago

Lead Engineer, Quality Validation

Katalyst Healthcares and Lifesciences

•

Andover, Massachusetts, USA

Full-time

Job Description: The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process. Responsibilities: Provide quality oversight of Bl
Posted 1 day ago | Updated 3 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Waltham, Massachusetts, USA

Full-time

Responsibilities: Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution. Ensure deliverables meet the overall facility milestones. Perform and support periodic assessment review and revalidation activities. Ensure deliv
Posted 1 day ago | Updated 3 hours ago

Senior Manager - Product Delivery Analysis

Fidelity Investments

•

Boston, Massachusetts, USA

Full-time

Job Description: Senior Manager - Product Delivery Analysis | Fidelity Digital Assets Fidelity Digital Assets (FDA) is dedicated to building products and services that help customers adopt digital assets and innovate within the increasingly digital world of finance. Fidelity Investments began researching blockchain technology and digital assets solutions in 2014, where years of research and development have provided us with the deep expertise necessary to build the future of finance. As a Seni
Posted 30 days ago | Updated 8 hours ago

Product Manager

Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

This is a medical technology company that specializes in building devices to help patients improve their overall wellbeing and health. They are currently hiring a fulltime Product Manager to work on their transcranial magnetic stimulation (TMS) products. Which is a FDA-cleared for the treatment of depression. The TMS technology uses Magnetic Stimulation aimed at key areas of the brain involved in emotional regulation, cognitive function, and self-control. By activating neural pathways, it helps
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Posted 43 days ago | Updated 11 hours ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 22 days ago

Sr. Quality Assurance Manager - Manufacturing/Med Device

Zachary Piper Solutions, LLC

•

Chelmsford, Massachusetts, USA

Full-time

Piper Companies is hiring a Senior Manager of Quality Assurance (Manufacturing/Medical Device) for a medical device company located in Chelmsford, MA. The Senior Manager of Quality Assurance (Manufacturing/Medical Device) will oversee QA Operations, derive continuous improvement initiatives and foster a culture of quality across the organization. The Senior Manager of Quality Assurance (Manufacturing/Medical Device) will need to work onsite 5 days per week in Chelmsford, MA. Responsibilities fo
Posted 6 days ago | Updated moments ago

Product Manager - Medical Devices

Motion Recruitment Partners, LLC

•

Marlborough, Massachusetts, USA

Full-time

A medical device manufacturer and distributor in Marlborough is looking for talented Product Managers to join their team. They recently launched a novel FDA approved medical device that is being used to treat impulse control, addiction, and depression. This product has the potential to be revolutionary in the mental wellness space. They are looking for Product Managers who hav a strong background in medical device product management with a background either in biology or biomechanical engineeri
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Posted 23 days ago | Updated 11 hours ago

Software Test Engineer - Enabling Tech R&D

Johnson & Johnson

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Remote or Warsaw, Indiana, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 3 days ago | Updated 3 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Boston, Massachusetts, USA

Full-time

Responsibilities: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports. Perform Data Integrity Assessments and review s
Posted 1 day ago | Updated 3 hours ago

Application Support

Beacon Systems, Inc

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Remote

Part-time

Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. We are looking for a Data and Applications Assistant - Remote - Providence, RI Request you to make sure your updated Resu
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Posted 8 hours ago

UX Designer/ UX Writer

Beacon Systems, Inc

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Remote

Contract

Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide.We are looking for aUX Designer / UX Writer - Remote- Orlando, FLRequest you to make sure your updated Resume highlights a
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Posted 14 days ago | Updated 9 hours ago

UX Writer

Beacon Systems, Inc

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Remote

Third Party, Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position Title: Hybrid UX Designer / UX Writer Duration: Long Term Location: Remote- Orlando,
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Posted 14 days ago | Updated 8 days ago

MES Consultant

BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact
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Posted 10 days ago

Clinical Research Associate

Zachary Piper Solutions, LLC

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Remote

Full-time

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s
Posted 30 days ago | Updated moments ago

Senior UX Designer (Hospitality, Travel, or Entertainment)

Beacon Systems, Inc

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Remote

Third Party, Contract

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position: Senior UX Designer Location: Remote - Orlando FL Duration: Long Term Summary: We are
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Posted 8 days ago

Verification Engineer & Validation R&D Engineer

Katalyst Healthcares and Lifesciences

•

Raynham, Massachusetts, USA

Full-time

Responsibilities: Establish equipment requirements by working closely with product design team, suppliers and the multi-functional project team. lign the equipment specifications to reliability and quality requirements within the framework of new products development or management of legacy products. pply Analytical and quantitative problem-solving using methods including but not limited to Root Cause Analysis and Design of Experiments. Define Manufacturing Process Flow, Master Validation Plan f
Posted 1 day ago | Updated 3 hours ago