Senior Associate, Plant Quality Assurance ReplimuneSenior Associate, Plant Quality AssuranceFramingham, Massachusetts$99,500–$128,500 / yearThe 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.
Quality Manager What we do- AspenQuality ManagerEast Providence, Rhode IslandThe ideal candidate must be able to lead through ambiguity, stabilize quality performance during supplier/process changes, support customer escalations, and develop a high-performing Quality Engineering team capable of sustaining IATF 16949 expectations, automotive core tools, product validation, traceability, and continuous improvement. The Quality Manager will ensure that quality processes are not only documented but effectively implemented on the manufacturing floor including control plans, quality gates, incoming inspection, process controls, layered audits, nonconformance management, APQP, PPAP, supplier qualification, and customer-specific requirements.
Sr Quality Engineer, Design Assurance Integra LifeSciences Holdings Corp.Sr Quality Engineer, Design AssuranceBraintree, MA$81,650–$112,700 / yearThe Design Quality Assurance Engineer (DQA) is responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation project(s) of varying scope and complexity in the Tissue Technology (TT) division, as well as risk management work for new and existing products. Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects.
Lead Auditor, Quality Compliance Integra LifeSciences Holdings Corp.Lead Auditor, Quality ComplianceMansfield, MA$109,250–$149,500 / yearThe Lead Auditor, Quality Compliance will form part of the Corporate Audit team and will lead, coordinate and perform corporate audits of the Quality Management System (QMS) as part of Integra LifeScience's quality internal audit program across more than 15 design, manufacturing, and distribution facilities and a diverse portfolio of leading medical devices. The incumbent will possess extensive GMP audit experience and practical skills including: the ability to write objective technical audit reports, evaluate and make objective judgments on technical issues arising during the audit, utilize multi-cultural sensitivity while driving audits forward consistently and on time, as well as project and time management.
Validation Quality Technician LancesoftValidation Quality TechnicianActon, MA$28The Quality Technician collaborates with Quality Engineering to ensure new and existing products conform to the *** Quality System, Quality System Regulation, ISO 13485 and ISO14971 throughout the design transfer to manufacturing process as well as product lifecycle. The Quality Technician is responsible for executing Test Method Validations, Process Validations, and other engineering studies in accordance with written protocols and procedures to maintain the validated state of ***’s product manufacturing and quality processes.
Principal Associate I, Plant Quality Assurance - 2ND SHIFT ReplimunePrincipal Associate I, Plant Quality Assurance - 2ND SHIFTFramingham, Massachusetts$120,000–$155,000 / yearThe Principal Associate I/II, Plant Quality Assurance (PQA) reports to the Associate Director, Quality Assurance and is responsible for on-going Quality oversight to ensure real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities according to current good manufacturing practices (cGMP), good documentation practices (GDP) and other applicable regulations. 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.
Senior Director, Quality Repligen CorporationSenior Director, QualityWaltham, Massachusetts$191,250–$260,000 / yearAs a member of the Global Quality Leadership Team, reporting directly to the VP Global Quality, you will partner closely with Operations, Commercial, Product Management, Supply Chain, Regulatory Affairs, and senior business leaders to establish a culture of quality excellence, operational performance, and continuous improvement throughout the network. Lead and execute the quality strategy across Repligen’s Filtration & System networks, with accountability for Quality Assurance, Quality Systems, Quality Compliance, Validation, Quality Control, Supplier Quality partnership, and Customer Quality activities.
Director Of Quality Catalent Pharma Solutions, Inc.Director Of QualityChelsea, MA$168,750–$257,800 / yearDemonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience; The anticipated salary range for this position in Massachusetts is $168,750-$257,800. 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.
Enterprise Data Quality Leader, Vice President State StreetEnterprise Data Quality Leader, Vice PresidentBoston, MassachusettsThe successful candidate will play a key role in strengthening enterprise capabilities for data quality management, controls, measurement and reporting, exception and issue management, and BCBS 239-aligned risk data aggregation and reporting outcomes using the Collibra Platform and related technologies. Define strategy to governance structure to drive continuous improvement of enterprise Data Quality Error Management and Data Quality Issue Management processes, including effective escalation paths, and senior management engagement as needed.
Director Of Quality Assurance - CMO/ CDMO RPM ReSearchDirector Of Quality Assurance - CMO/ CDMOWaltham, MassachusettsHas knowledge and skills across a range of Quality practices, procedures, and principles, with an astute ability to easily rank priorities based on importance and feel comfortable making decisions on quality issues. Demonstrate knowledge of and instruct department procedures and company policies, pay attention to detail in all areas, and ensure all the paperwork is completed completely, neatly, and fully.
Quality Systems Specialist I Cirtec Medical Corp.Quality Systems Specialist ILowell, MA$70,000–$80,000 / yearFull timeOur expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems. Associates of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
Senior QA Specialist Editas MedicineSenior QA SpecialistCambridge, MA$110,000–$120,000The primary focus of this role in the next 12 months is to advance our lead in vivo development candidate, EDIT-401, into the clinic to establish human proof of concept by ensuring compliance with FDA, cGMP, and international regulatory requirements across manufacturing, testing, product disposition, and quality event management. Author, review, and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, specifications, and summary reports) supporting GMP manufacturing.
HVAC Controls Technician II Daikin Applied AmericasHVAC Controls Technician IIBoston, Massachusetts$37.90–$60.46 / hourThe HVAC Controls Technician II position for Building Automation Systems (BAS) is critical to our success in ensuring our customers receive top-notch service as it relates to the installation, programming, and service of commercial digital control systems while maintaining quality and profitability. The opportunity to work on all types of commercial equipment and cutting-edge technologies such as Intelligent Equipment, Magnetic Bearing Technology, and VRF Technology.
NewSenior Associate, Quality Assurance Replimune Group, Inc.Senior Associate, Quality AssuranceFramingham, MA$106,000–$137,000 / yearThe 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. Support the oversight of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
NewAIR Quality Specialist I State of Rhode IslandAIR Quality Specialist IProvidence, RI$73,210–$82,203 / yearREQUIRED QUALIFICATIONS FOR APPOINTMENT: KNOWLEDGES, SKILLS AND CAPACITIES: A working knowledge of the basic principles, practices, procedures and technology employed to preserve, protect and improve the air resources of the state; a working knowledge of the state laws and regulations as they relate to air quality and the ability to interpret and apply such laws; the ability to conduct research on the identification, causes and effects of air pollution; the ability to prepare scientifically accurate reports on, and develop technical plans for air quality programs; the ability to gather and analyze technical and/or statistical data; the ability to communicate effectively both orally and in written form; the ability to establish and maintain effective working relationships with associates, other government officials, stakeholders and partners; and the ability to engage in field work as required. ILLUSTRATIVE EXAMPLES OF WORK PERFORMED: To perform routine and various scientific or engineering work and duties necessary to implement and conduct programs and projects related to environmental compliance, permitting or management as it pertains to air pollution; and to do related work as required.
Senior Quality Scientist I AddgeneSenior Quality Scientist IWatertown, MAFull timeAs an “Addgenie”, you will work collaboratively with internal teams to help fulfill this mission, including scientists, software engineers and product developers, renowned customer support teams, scientific content creators, and business development professionals. Since its founding in 2004, Addgene has grown and innovated in order to assist the research community by archiving and sharing useful DNA-based research materials and resources (such as plasmids, viral vectors, and recombinant antibodies) with scientists worldwide.
Principal Associate II, Quality Assurance Operations Replimune Group, Inc.Principal Associate II, Quality Assurance OperationsFramingham, MAThe 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. For this role, the anticipated base pay range is $134,000 $173,500 The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience.
Associate II, Plant Quality Assurance Replimune Group, Inc.Associate II, Plant Quality AssuranceFramingham, MA$90,000–$116,500 / yearSummary of job description: The Associate II, 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.
Engagement Manager - Life Sciences Quality Veeva SystemsEngagement Manager - Life Sciences QualityBoston, MA$85,000–$210,000 / yearUnlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. Account Leadership: Build and navigate senior customer relationships, leading proposals for significant project wins and driving long-term account strategy.
Senior Associate, Plant Quality Assurance Replimune Group, Inc.Senior Associate, Plant Quality AssuranceFramingham, MA$99,500–$128,500 / yearSummary of job description: The 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.