Staff Design Control Engineer, Design Quality (IVD/CDx/Medical Device)) Quest Diagnostics IncStaff Design Control Engineer, Design Quality (IVD/CDx/Medical Device))Marlborough, MA$105,000–$125,000 / yearThe Staff Design Quality Engineer is a highly experienced technical quality leader responsible for quality oversight of complex IVD medical device development programs, high-risk changes, and technically demanding validation and design transfer activities. Provide authoritative review and approval of key design control deliverables, including design and development plans, requirements, risk files, validation strategies, design reviews, traceability matrices, and transfer packages within delegated authority.
Director, Quality Control Editas MedicineDirector, Quality ControlCambridge, MA$215,000–$235,000 / yearThe successful candidate will collaborate with a high-performing CMC team, coordinating with process and analytical experts cross-functionally in Research and Discovery, Process Development, Analytical Sciences, Manufacturing, and Quality Assurance, to transfer, qualify and oversee in-process and release testing to advance Editas’ in vivo gene medicine portfolio. The Quality team is seeking a highly motivated and experienced technical and organizational leader in gRNA, mRNA, and Lipid Nanoparticle (LNP) analytical methodologies and GMP testing.
Senior Director, Biologics Analytical Development and Quality Control Korsana BiosciencesSenior Director, Biologics Analytical Development and Quality ControlBoston, MassachusettsThis leader will oversee the planning and execution of outsourced analytical development and testing activities and will work proactively with external suppliers including CDMOs and contract labs to define project scope, mitigate risks, and ensure successful delivery in relation to technical quality, timelines and budget. Collaborates with internal stakeholders in the areas of Drug Substance Development, Drug Product Development, Combination Product Development, Clinical Supply Chain, Program Management, Preclinical Development, Clinical Development/Operations, Quality, Regulatory Affairs, and external business partners to push project forward.
Scientist I, Quality Control Replimune Group IncScientist I, Quality ControlFramingham, 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. The QC Analytical Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, drug substance and final drug product samples following established test method (SOPs).
Sr. Quality Specialist, GxP Document Control Bicara TherapeuticsSr. Quality Specialist, GxP Document ControlBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Sr. Quality Control Analyst Pace Analytical ServicesSr. Quality Control AnalystWaltham, Massachusetts$105,000–$120,000 / yearDesign and develop robust, scalable formulations for small molecules and biologics in early-stage clinical trials; optimize manufacturing processes for drug products. Analyze and interpret complex chemistry, biochemistry, and formulation data to identify trends and provide actionable insights to management and/or clients.
Quality Change Control, Project Manager (Contract) 665 Vertex PharmaceuticalsQuality Change Control, Project Manager (Contract) 665Boston, Massachusetts$58–$65 / hourFull timeAgreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners. Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
Sr. Quality Control Analyst LNN Pace Analytical Life SciencesSr. Quality Control AnalystWaltham, Massachusetts$35–$50 / hourSUMMARY Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.
Director, Quality (Contamination Control and Microbial Excellence) Thermo Fisher Scientific IncDirector, Quality (Contamination Control and Microbial Excellence)MA$145,500–$218,250 / yearProvide subject matter expertise (SME) in microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning and disinfection and other relevant areas required by site CCME teams and corporate quality management. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Quality Control Sample Management Technician - Microbiology (2nd Shift) Rentschler BiopharmaQuality Control Sample Management Technician - Microbiology (2nd Shift)Milford, MassachusettsPerforms a variety of sample management duties, including labeling, preparing samples for shipment, transporting to laboratories or Supply Chain, maintaining inventory, and discarding samples as needed. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law.
Scientist I, Quality Control Replimune Group, Inc.Scientist I, Quality ControlFramingham, 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. The QC Analytical Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, drug substance and final drug product samples following established test method (SOPs).
NewSenior Scientist, Analytical Development and Quality Control Flagship Pioneering, Inc.Senior Scientist, Analytical Development and Quality ControlCambridge, MA USA$126,000–$181,500 / yearThe current Flagship ecosystem comprises 41 transformative companies, including: Axcella Health (NASDAQ: AXLA), Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics, Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology, Seres Therapeutics (NASDAQ: MCRB), and Syros Pharmaceuticals (NASDAQ: SYRS). Flagship Pioneering has created over 100 groundbreaking companies over the past twenty years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability.
Senior Scientist, Analytical Development and Quality Control Flagship Pioneering IncSenior Scientist, Analytical Development and Quality ControlCambridge, MA$126,000–$181,500 / yearThe current Flagship ecosystem comprises 41 transformative companies, including: Axcella Health (NASDAQ: AXLA), Denali Therapeutics (NASDAQ: DNLI), Evelo Biosciences (NASDAQ: EVLO), Foghorn Therapeutics, Indigo Ag, Kaleido Biosciences (NASDAQ: KLDO), Moderna (NASDAQ: MRNA), Rubius Therapeutics (NASDAQ: RUBY), Sana Biotechnology, Seres Therapeutics (NASDAQ: MCRB), and Syros Pharmaceuticals (NASDAQ: SYRS). Flagship Pioneering has created over 100 groundbreaking companies over the past twenty years, all of which are pioneering novel and proprietary biological, industrial, and engineering approaches to solve major needs in human health and sustainability.
Gas Quality Control Analyst Eversource EnergyGas Quality Control AnalystWrentham, MA$95,600–$106,220 / yearRole and Scope of Position: Supports the implementation, of the Eversource Quality Control (QC) program as it relates to any of the following construction, maintenance, meter service, leak survey, corrosion, damage prevention, LNG and I&R activities at Eversource Gas. We promote natural gas as a safe, reliable, and efficient energy option while building and maintaining pipeline delivery systems and storage facilities to ensure affordable access for residential, municipal, commercial, and industrial customers.
Quality Control Analyst, II Vericel CorpQuality Control Analyst, IIBurlington, MA$33.65–$38.46 / hourPosition Summary: Responsible for performing routine and non-routine assays of raw materials, in-process samples, drug product (DP), and stability samples within the QC laboratory in accordance with SOPs for product release and validation. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).
Quality Operations Program Manager - Document Control Veeva Systems IncQuality Operations Program Manager - Document ControlBoston, MARemote$100,000–$150,000 / yearServe as System Administrator of Veeva's internal electronic Document Management System (eDMS), responsible for system configuration, user administration, lifecycle management, and continuous improvement of the system and its governed processes. We're not just any public company - we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.
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.
Field Control Inspector (Civil Engineer II) Commonwealth of MassachusettsField Control Inspector (Civil Engineer II)Hopkinton, MAIncumbents of positions in this series prepare or review plans, designs, specifications and cost estimates for engineering projects; prepare and/or review reports, studies and analytical data; perform calculations relating to engineering problems; perform engineering surveys; inspect construction and / or maintenance work; and perform related work as required. Applicants must have at least (A) three years of full-time, or equivalent part-time, technical or professional experience in civil engineering work in such areas as construction, survey, design, transportation, hydraulics, structural, sanitary, drafting, environmental, highway, architectural, airport, soils and materials, of which (B) at least one year must have been in a professional capacity, or (C) any equivalent combination of the required experience and the substitutions below.
Quality Inspector GTT, LLCQuality InspectorMarlborough, MASupport manufacturing personnel by ensuring proper documentation of Failure Investigation Reports and processing of Non-Conforming Materials in the Product Lifecycle Management (PLM) system, including identification, quarantine, and documentation. The Quality Inspector will perform detailed inspection and documentation review activities supporting finished product release, in-process quality, and regulatory compliance within a medical device manufacturing environment.
Quality Inspector I Materion CorpQuality Inspector INewton, MAThe candidate selected will have to qualify as either a U.S. citizen, a U.S. National, a lawful permanent resident of the U.S., a Person Admitted into the U.S. as an Asylee or Refugee., a National of a country that is not prohibited from having access to U.S. controlled technology (via a letter of assurance), or a Person to be approved for an export license by the governing agency whose technology comes under its jurisdiction. The selection of the person to be hired for this position is contingent on the candidate having export compliance eligibility for access to U.S. controlled technology which comes under the licensing jurisdiction of the U.S. Department of State, International Traffic in Arms Regulations (ITAR) and the U.S. Department of Commerce, Export Administration Regulations (EAR).