- Merck & Co. (Durham, NC)
- …ingredient, finished product and support laboratory testing for vaccines.The Quality Control Laboratory Associate Specialist participates on a team ... Job DescriptionWe are seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating… more
- Novo Nordisk Inc. (Durham, NC)
- …with stakeholders through engagement & positive cooperation Perform & oversee change control activities for QC equipment & systems Support systematic problem ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory … more
- Novo Nordisk Inc. (Durham, NC)
- …Novo Nordisk and help us make what matters. The Position Works closely with Laboratory personnel to support repairs, preventive maintenance & calibration of ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...with a minimum of seven (7) years of intense laboratory instrumentation experience in the pharmaceutical industry required Minimum… more
- Insmed Incorporated (San Diego, CA)
- …CMC team.Perform quality management activities such as deviation, CAPA, change control , investigation of OOS, OOT and anomalous results within the company QMS ... phase appropriate qualification/validation protocols and reports of QC methods to support product release and characterization. The role will perform potency… more
- Battelle (West Jefferson, OH)
- …for applying technical expertise to maintain the design basis, management and control configuration, and performance of critical facilities systems in support ... are kept current on a per project and/or annual basis.Ensures formal work control and change control processes are followed. Maintains configuration documents… more
- Novo Nordisk Inc. (Boulder, CO)
- …manufacturing of oligonucleotides and associate raw materials if applicable. Experience in quality control , analytical method, transfer, and qualification in a ... Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development,… more
- Merck & Co. (Rahway, NJ)
- …Description Position Description: As a member of our company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance ... oversight for computer system validation matters within the Global Development Quality organization and for the company's R&D division.For company's Clinical Supply,… more
- Merck & Co. (Durham, NC)
- …at all levels in the organizationFUNCTIONAL EXPERTISE: The Specialist, Quality Control will be responsible for activities that support cGMP and regulatory ... understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support .Collaborate with internal… more
- Aequor (Melville, LA)
- …requirements.Coordinate sample pulls from protocol requirements, pull samples and submits to Quality Control Laboratory . Prepare sample labels and aliquot ... change batches monitored on the stability program and to support the QC Laboratories with sample receipt/ control ...all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, and… more
- Insmed Incorporated (Bridgewater, NJ)
- …years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug ... and global company policies & proceduresLead overall management of Quality Assurance programs to support the QC...PM, etcReview and approve deviations, CAPAs, SOPs and Change Control related to QC Lab and operationsPartners within QA… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …functions that impact production, increase efficiency, create cost savings, improve quality , and provide new product support .Operate and troubleshoot procedures ... major equipment, important systems, instrumentation, and computerized systems.Knowledge of quality systems including exception management, change control ,… more
- Tris Pharma (Monmouth Junction, NJ)
- …takes a leadership role for other chemists on the QA R&D team in supporting Quality Control (QC) and Analytical R&D (AR&D) activities. These include but are not ... softwareExperience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and… more
- BioAgilytix (Boston, MA)
- …according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance ... of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (eg GLP, GMP) and non-regulatedIdentify deviations, OOS and… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- The Bartech Group Inc (Marysville, OH)
- …product specification while ensuring continuous improvement of Safety, Environment, Quality , Delivery, Cost and Morale (SEQDCM) characteristics.Develop and maintain ... Weld (RSW) and Gas Metal Arc Welding (GMAW) welds. Produce New Model quality documentation for weld specific information. Install and maintain new welding technology… more
- Catalent (St. Petersburg, FL)
- …with other functional areas (eg Product Development, Operations, Customer Service, Validation, Quality Control , etc.) to ensure continued compliance for the ... experience as QA in pharmaceutical industries. Prior experience working with quality control , manufacturing, product development preferred (Feasibility Batches,… more
- Novo Nordisk Inc. (Boulder, CO)
- …Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, ... the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals...responsible for the production of non-cGMP oligonucleotide API to support toxicology studies. In addition to ensuring the supply… more
- Novo Nordisk Inc. (Boulder, CO)
- …Nordisk's acquisition of Dicerna Pharmaceuticals, Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, ... the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals...responsible for the production of non-cGMP oligonucleotide API to support toxicology studies. In addition to ensuring the supply… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Organism Identifications to the genus and species level. Perform Growth Promotion/ Quality Control Testing of Microbiological media and/or materials used ... Position Summary The Microbiologist I will perform Microbiological laboratory testing associated with Environmental Monitoring (EM), Water for Injection (WFI), and… more
- Tris Pharma (Monmouth Junction, NJ)
- …working in Analytical Research and Development (AR&D), Method Validation (MV) and/or Quality Control (QC) or related laboratories.Special knowledge or skills ... under the direct supervision of laboratory management, the incumbent carries out laboratory work to support MV and QC activities and performs special… more
