Quality Control / Documentation Analyst Katalyst Healthcares & Life SciencesQuality Control / Documentation AnalystLexington, MAJob Description: Assist in document authoring/ revision and approval (protocols, test methods, SOPs) and other routine laboratory activities supporting the lab as 079 activities are completed by the biochem team. This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.
Data Integrity Program Manager - Quality Control Rentschler BiopharmaData Integrity Program Manager - Quality ControlMilford, MassachusettsThe QC Data Integrity Program Manager, will be responsible for ensuring compliance and alignment to all relevant regulatory and internal requirements related to data integrity as well as developing training material and leading training efforts with Quality Control Staff. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.
Senior Manager, Analytical Development & Quality Control Alpha-9 OncologySenior Manager, Analytical Development & Quality ControlBoston, MassachusettsAlpha-9 Oncology is seeking a highly motivated Senior Manager, Analytical Development & Quality Control, to provide technical and operational leadership for quality control and analytical lifecycle activities across clinical-stage radiopharmaceutical programs. This role will serve as a primary analytical and QC representative supporting development programs through data trending, statistical analysis, batch release support, investigation management, CDMO oversight, analytical readiness activities, and clinical supply support.
Quality Control Microbiologist RD PartnersQuality Control MicrobiologistNorton, Massachusetts£74,880–£93,600Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs. R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering.
Research Associate II, Quality Control Ocular TherapeutixResearch Associate II, Quality ControlBedford, MA$85,000–$93,000 / yearOcular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX. This position will support CAPA's, change controls, investigations, and deviations and participate in the development and validation of analytical methods for the Analytical Development group.
Data Review Specialist, Quality Control Ocular TherapeutixData Review Specialist, Quality ControlBedford, MA$98,000–$113,000 / yearPosition Summary: The Data Review Specialist will apply strong technical knowledge of laboratory operations, analytical data review, data integrity requirements, and quality systems to perform thorough reviews of analytical chemistry, microbiology, stability, and release testing data for accuracy, completeness, scientific soundness, and compliance with cGMP, GLP, and ALCOA+ expectations. In addition to data review, this role will support QC data monitoring activities, including evaluation of release data, raw material testing data, and stability data trends to identify emerging patterns, atypical results, potential OOT signals, and opportunities for improved product understanding.
Environmental Monitoring Associate - Quality Control TandymEnvironmental Monitoring Associate - Quality ControlBedford, Massachusetts$32 / hourThis role supports controlled manufacturing operations by performing environmental monitoring, utility sampling, documentation, and microbial enumeration in a GMP-regulated setting. Perform environmental monitoring tasks for aseptic and controlled areas, as well as plant utility systems, following SOPs and GMP documentation.
Quality Control Analyst I, Raw Materials Ocular TherapeutixQuality Control Analyst I, Raw MaterialsBedford, MA$68,000–$75,000 / yearOcular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX. Key Responsibilities: The primary responsibilities of this role will be performing qualitative and quantitative testing of raw materials using techniques such as HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
Senior Scientist I, Quality Control Candel Therapeutics Inc.Senior Scientist I, Quality ControlNeedham, MA$155,000–$160,000 / yearThis position collaborates with external manufacturing and tech transfer and is focused on Adenovirus and Herpesvirus vectors, associated cell-based potency assays, as well as performing training of new technical staff and troubleshooting and validation of new and established assays. A strong background in one or more analytical techniques such as various HPLC based methods, microplate UV/Vis/Luminescent assays, cell-based assays including virus quantification and potency, qPCR, electrophoresis, sizing techniques such as DLS, etc.
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.
Quality Control (Metrology Lab/Med device Night Shift & 2nd) SmcQuality Control (Metrology Lab/Med device Night Shift & 2nd)MassachusettsThis position has primary responsibilities which include accurate part and assembly inspections and tests performed to customer specifications, operating computerized inspection systems, such as coordinate measurement machines and vision inspection equipment. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.
Director, Quality Control Editas Medicine, Inc.Director, 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. Characterizing Your Impact: As the Director, Quality Control, you will: Lead phase appropriate CMC analytical development, qualification/validation, transfer and optimization through strong collaboration with key stakeholders and external partners.
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.
NewQuality Control Analyst Actalent IncQuality Control AnalystCambridge, MA$35–$40 / hourThe Quality Control (QC) department is essential for ensuring compliance with cGMP operations through the inspection of components and raw materials, as well as quality testing of intermediate, stability, and final product samples. 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.
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.
Quality Control Analyst LanceSoft IncQuality Control AnalystLexington, MA$34–$37.29 / hourJob Description Assist in document authoring/ revision and approval (protocols, test methods, SOPs) and other routine laboratory activities supporting the lab as 079 activities are completed by the biochem team. This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.
Director, Quality Control Dyne TherapeuticsDirector, Quality ControlWaltham, MA$190,000–$230,000 / yearThe Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and commercial stages. Regulatory, Inspection Readiness & Cross-Functional Collaboration Prepares and reviews analytical CMC content for regulatory submissions (INDs, BLAs) and supports interactions with global health authorities.