Senior Manager, GMP QA Operations Dyne TherapeuticsSenior Manager, GMP QA OperationsWaltham, MA$160,000–$195,000 / year4+ years of related work experience in Quality Assurance or closely related role within Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry, preferably with experience overseeing CMO/CDMO organizations. Leads tactical GMP QA operations supporting manufacturing, testing, deviation investigations, and CAPA implementation to enable compliant product disposition for clinical development and future commercialization.
Quality Assurance Specialist - Supplier Quality Actalent IncQuality Assurance Specialist - Supplier QualityHopkinton, MA$38–$40 / hourExperience supporting supplier quality activities, including supplier qualification and assessments, performance monitoring, corrective and preventive action (CAPA) management, and change control processes. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
Quality Assurance Engineer, Manufacturing XometryQuality Assurance Engineer, ManufacturingWaltham, MA$84,000–$109,000 / yearXometry’s digital marketplace gives manufacturers the critical resources they need to grow their business while also making it easy for buyers at Fortune 1000 companies to tap into global manufacturing capacity. Enhance Supplier Quality Culture by leading or participating in process improvement projects to further develop the quality programs and procedures - Setting our Global Partner Network up for success.
QA/QC Specialist I Integrated Resources, IncQA/QC Specialist ILexington, MassachusettsContractorJob DescriptionPosition Details:Location Lexington, MAJob Title QA/QC Specialist 1Duration 6+ MonthsJob Function and Description:To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and perform GMP release of IMP and to ensure compliance with market regulations. QA/QC Specialist IA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
NewDirector Software Quality Assurance Johnson ControlsDirector Software Quality AssuranceWestford, Massachusetts$141,000–$237,000 / yearThis role requires a strong technical and people leader who can drive quality excellence across globally distributed teams while supporting products that help protect people, property, and critical infrastructure around the world. This leader will be responsible for driving software quality across a portfolio of mission-critical fire solutions including embedded systems, firmware, cloud platforms, mobile applications, web applications, and connected products.
Associate Director, GMP QA Operations Dyne TherapeuticsAssociate Director, GMP QA OperationsWaltham, MA$160,000–$195,000 / yearThe Associate Director, QA Operations serves as the QA technical lead for external manufacturing and testing project teams, ensuring the effective development, implementation, and continuous improvement of Quality Systems, procedures, policies, and metrics supporting GMP activities. 5+ years of related work experience in Quality Assurance or closely related role within Medical Device, Diagnostic, Pharmaceutical, or other similar regulated industry, preferably with experience overseeing CMO/CDMO organizations.
Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU) PrileniaDirector / Senior Director, GCP Quality Assurance Lead (US/IL/EU)Europe, MassachusettsRemoteAbout Prilenia Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Director/Senior Director, GCP Quality Assurance Lead, to support programs in both Huntington’s Disease and ALS. The ideal candidate is both a hands-on quality practitioner and a strategic partner to Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics, combining deep GCP/GvP/GLP expertise with the executive presence to influence cross-functional teams and senior leadership.
QA officer (Controls Testing) Syntricate Technologies IncQA officer (Controls Testing)Nashua, FLAppropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Banking, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behaviour, conduct and business practices, and escalating, managing and reporting control issues with transparency. Help contribute to the Lessons Learned Policy, including monitoring of control breaches and dissemination and learnings across other business units for process improvement to limit the occurrence of similar future events and where similar risk exposure might exist.
Senior Quality Assurance Document Specialist Candel TherapeuticsSenior Quality Assurance Document SpecialistNeedham, MAFull timeEssential Areas of Responsibility: Administers Document Management Program and provides support to end users for the creation, revision, and retirement of documents including: Reviews GxP documents and records for completeness and compliance with internal procedures and applicable regulations and ensures ALCOA++ principles are followed to ensure data robustness. Administers the Training Management Program and provides support to end users for the maintenance of training activities including: Maintains user roles, training curricula, and training assignments.
Senior QA Engineer Magna International, IncSenior QA EngineerLowell, MassachusettsAs a Senior Quality Assurance Engineer at Magna New Mobility, you will play a key role in setting up the testing strategy and tools for testing cloud software systems and features from the ground up. Magna New Mobility is a business unit inside Magna International leveraging Magna's technology building blocks, developing new capabilities, and entering new markets and use cases.
Quality Assurance Specialist II Catalent IncQuality Assurance Specialist IIChelsea, MA$72,781–$96,069 / yearImportant Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
QA Engineer Threat StackQA EngineerBoston, MassachusettsOur platform gives our customers deep visibility into the behaviors of their systems and helps to identify potentially anomalous actions of users and processes. This person not only wants to produce a quality application for our customers, but also wants to make the QA process easier and faster over time by building out automation and contributing to best practices.
QA Technician I LancesoftQA Technician IBurlington, MA$20This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Mailroom Quality Assurance Associate Global Channel ManagementMailroom Quality Assurance AssociateMassachusettsMonitors all aspects of required Corporate directed training to ensure completion target dates are met and meets targets for all other duties as assigned. · Performs and documents required monthly user reviews for associates access, both data and physical and additional security requirements to meet control objectives.
Senior Associate, Plant Quality Assurance ReplimuneSenior Associate, Plant Quality AssuranceFramingham, MassachusettsThe Senior Associate, Plant Quality Assurance (PQA) reports to the Manager, Plant Quality Assurance and is responsible for providing day-to-day Quality oversight to support Drug Substance, Drug Product, and Quality Control operations in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulatory requirements. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
QA/ QC / Quality Technician Intellectt INCQA/ QC / Quality TechnicianBurlington, MAIf you're currently looking for a new role or considering a change from your current position. Ensure compliance with FDA, ISO 13485, and Quality Management System (QMS) requirements.
3rd Shift Mail QA Clerk Global Channel Management3rd Shift Mail QA ClerkMassachusettsPerforms and documents required monthly user reviews for associate?s access, both data and physical and additional security requirements to meet control objectives. 3rd Shift Mail QA Clerk duties: Provides critical information for audits and reviews/analyzes data and documentation.
Quality Assurance Technician $23- $27.00 Ultimate Staffing ServicesQuality Assurance Technician $23- $27.00Sutton, MA, Massachusetts$23–$27 / hourRESPONSIBILITIES: Follows all procedures in the ISP Quality Management System, works safely and adheres to lockout, tagout procedures, all safety postings and policies, asks questions when in doubt, and escalates improvements, ideas, and concerns quickly. The QA Tech will use a variety of measurement tools daily including analog, digital, and electronic calipers and micrometers, durometers, vision systems, laser measurement systems.
QA Associate Integrated Resources, IncQA AssociateBillerica, MassachusettsFull timeVerify that lab testing data based on the protocol guidance has been accurately captured in the report template• Reviewing data tables and laboratory records• Perform all function of a document controller and training administrator including, but not limited to, processing requests for new documents, revising existing documents, coordinating document validity reviews, entering information into the document and training databases and maintaining associated electronic and hard copy records• Issue controlled documentation for laboratory test data packages• Provide support as needed to administrative staff and validation project coordinators including scanning and filing documents, revising/editing documents, making photocopies and preparing customer mailings. Job Description• The Quality Assurance Specialist will work directly with validation project coordinators, technical area representatives and laboratory management• Primary responsibilities are reviewing laboratory test protocols and reports, coordinating SOP document revisions, entering electronic training records, maintaining tracking spreadsheets and filing paper copies of laboratory records• Reviewing laboratory testing protocols• Verify that customer information from a questionnaire has been accurately and completely transcribed into a document template• Reviewing lab testing reports.