Quality Control Analyst II, Release & Stability Testing (3rd Shift - Contract) Rentschler BiopharmaQuality Control Analyst II, Release & Stability Testing (3rd Shift - Contract)Milford, MassachusettsThe Quality Control Analyst II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods, stability protocols, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP). SME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non-conformances.
Quality Control Data Reviewer Rentschler BiopharmaQuality Control Data ReviewerMilford, MassachusettsAs part of the Milford site’s Quality Control team, the Data Reviewer is responsible for the cGMP analytical data review and documentation generated during laboratory analysis in the quality control laboratory. 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.
Quality Control Systems Manager CharterQuality Control Systems ManagerMassachusettsDocumentation & Reporting Prepare and maintain required QC documentation, including daily QC reports, test results, deficiency logs, and meeting minutes. Types of work include environmental remediation, demolition, excavation, dredging, utility work, and landfill cap/closure projects.
Associate Director, Analytical Development & Quality Control Alpha-9 Oncology IncAssociate Director, Analytical Development & Quality ControlBoston, MAThe successful candidate will manage relationships with external manufacturing and testing partners while partnering closely with Quality, Regulatory, Technical Operations, and Program Leadership teams to support API development, CMC activities, and timely execution of clinical supply strategies. Alpha-9 Oncology is seeking a highly experienced and motivated Associate Director, Analytical Development & Quality Control, to provide technical and operational leadership for QC activities supporting our clinical-stage radiopharmaceutical programs.
Quality Control Analyst- Gas Operations EversourceQuality Control Analyst- Gas OperationsSouthborough, 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. This role works in an environment that often requires the performance of multiple simultaneous activities, where deadlines need to be met and work is performed under pressure while involving significant business commitments and results.
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.
NewSenior 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, Quality Control Analytical Development (6-month Contract) Rentschler BiopharmaScientist, Quality Control Analytical Development (6-month Contract)Milford, Massachusetts$45–$55 / hourPrimary focus on the execution of experiments to support the validation of molecular biology assays including but not limited to ELISAs for residual HCP, residual protein a, and relative potency assays as well as qPCR. Experience in other biophysical characterization methods CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H)PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping is a plus.
Claims Quality Control Auditor (44912) Neighborhood Health Plan of Rhode IslandClaims Quality Control Auditor (44912)Smithfield, RIResponsibilities include, but are not limited to the following: Review Neighborhood's claim process functions, including auto adjudicated and manually processed claims and issues, based on provider and health plan contractual agreements and claims processing guidelines. This Master IA will be created from results of the weekly Claims Adjustment Committee meeting and be used by adjusters from each delegate to reprocess claims according to the respective configuration changes in each system.
Document Control Manager - Quality, Compliance, and Oversight Massachusetts Bay Transportation AuthorityDocument Control Manager - Quality, Compliance, and OversightBoston, MAHave a satisfactory work record for the two (2) years immediately prior to the closing date of this posting (unless if current student or recent graduate), including overall employment, job performance, discipline, and safety records (infractions and/or offenses occurring after the closing of the posting and before the filling of a vacancy may preclude a candidate from consideration for selection). Bachelor's degree from an accredited institution in Business Administration, Engineering, Information Technology, Computer Science or a related field with 5 or more years of professional experience in business administration, library management, document management, information technology, training management or related field.
Scientist I, Quality Control ReplimuneScientist I, Quality ControlFramingham, MassachusettsThe 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).
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.
Sr. Quality Specialist, Gxp Document Control Bicara Therapeutics IncSr. Quality Specialist, Gxp Document ControlBoston, MAFICERA 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.
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.
NewScientist 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.
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.
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.
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).