- Insmed Incorporated (San Diego, CA)
- …Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality Assurance (CQA) serves ... role provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and national… more
- Merck & Co. (Rahway, NJ)
- …control, security certification such as Certified Professional Accountant (CPA), Certified Information Systems Auditor (CISA), Certified Internal Auditor (CIA), ... medical innovation and help improve lives.Our Company's Corporate Audit and Assurance Services' (MCAAS) primary purpose is to provide value-added independent and… more
- Spirit AeroSystems (Wichita, KS)
- …purchase contracts, customer specs, and regulations across manufacturing, quality systems , special processes, and product standards. Conduct comprehensive reviews of ... supplier interactions. Ensure suppliers establish and maintain approved Quality Systems per company and customer standards. Collaborate with suppliers...of Kansas Aviation tax credit for up to five years. Click here for more information on the tax… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...to complete tasks, know how to get resources and information from established internal contacts, and consult with supervisor… more
- MIT Lincoln Laboratory (Lexington, MA)
- …teams in which team members possess expertise in communications theory, networking, information assurance , systems engineering, antennas and arrays, digital ... The Advanced SATCOM Systems and Operations Group is developing technologies for.... Current research areas draw from advanced concepts in Information Theory, Communication Theory, Network Theory, Array Processing, Estimation… more
- Eisai, Inc (Raleigh, NC)
- …Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and ... products and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record review, SOP writing,… more
- BioAgilytix (Durham, NC)
- …build the rules, processes, and cloud pipelines that keep lab and business information accurate, secure, and easy to find. That means hands-on work designing Azure ... quality, access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements,… more
- Aequor (Houston, TX)
- …most likely cause of the deviation investigation o Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP documents (ie SOPs, ... the scope of their role under guidance of supervisor/manager o Generously shares information and knowledge with others across the team o Routine interaction with… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical staff to ... needs of manufacturing are considered as part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy ... studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping… more
- AUROBINDO (Durham, NC)
- …and training initiatives.HR Reporting & SystemsMaintain and update HRIS (Human Resources Information Systems ).Prepare reports on HR metrics such as turnover, ... of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several… more
- Merck & Co. (North Wales, PA)
- …clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical ... conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ability… more
- Eisai, Inc (Exton, PA)
- …with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program Management departments.The Associate ... cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and other internal (PST) and… more
- Merck & Co. (Durham, NC)
- …requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the US Equal Opportunity Employment laws, ... Operations, Manufacturing Processes, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance , Production Operations, Production Scheduling, Safety, Health, Environment and… more
- Merck & Co. (Rahway, NJ)
- …our Company's manufacturing division.Understanding of the existing IT portfolio of systems and products.- Understanding of the external technology landscape and the ... requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the US Equal Opportunity Employment laws,… more
- Merck & Co. (Upper Gwynedd, PA)
- …responses to health authority questions per established business processes and systems .-Identify, communicate and escalate potential regulatory issues to GRACS CMC ... operations (eg, manufacturing, formulation and process development, analytical, quality assurance , n ovel modality and technologies such as synthetic peptides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Required Master's Degree in Computer Science, Life Science, Engineering, or Information Systems - Preferred Experience10+ years of experience in GxP-regulated ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- Twist BioScience (South San Francisco, CA)
- …and process quality reports by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 ... in Operations/QCPreferred QualificationsKnowledge of/experience with Quality Control and Quality Assurance principles, including GMP/ISOKnowledge of molecular biology techniques such… more
- Merck & Co. (North Wales, PA)
- …clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise Designs and develops complex programming algorithms ... requirements - ** Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of… more
- Merck & Co. (Durham, NC)
- …and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role ... compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product Release, Change Control).-… more
