Katalyst HealthCares & Life Sciences

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Quality Engineering Consultant - Greater Phoenix Area, AZ Katalyst HealthCares & Life Sciences Overview: Our client, a leading medical device manufacturer, is seeking a mid-level Quality Engineering Consultant to join their team on a contract basis. In this role, you will be responsible for providing expert-level quality engineering support to ensure the company's medical devices meet all regulatory requirements and quality standards. Develop and implement quality control plans, including sampling strategies, inspection protocols, and testing procedures. Ensure compliance with relevant quality standards, regulations, and industry best practices (e.g., ISO 13485, FDA QSR, cGMP). Collaborate with cross-functional teams, including manufacturing, design, and regulatory affairs, to identify and resolve quality-related issues. Contact: [email protected] (or) [email protected] #qualityengineer #quality #qualitycontrol #wearehiring #hiringnow #jobforyou #jobalert #joboffers #joinourteam #joinwithus #lifesciences #katalysthls FDACenters for Disease Control and PreventionThe National Institutes of Health

Clinical Trails Manager - Neenah, WI Katalyst HealthCares & Life Sciences Overview: You take over the responsibility for global Supply Chain activities for Investigational Medicinal Products (IMPs) of national and international clinical trials for Biological (NBE) projects. In this role you act as the main point of contact to Clinical Development & Operations for assigned trials, ensuring the timely and cost-efficient provision of clinical supplies. With your comprehensive experience you will be the responsible leader of the CTSU trial team within the matrix structure, ensuring cross-functional collaboration and development of interfaces for all Supply Chain activities based on business, regulatory and industry needs. Contact: [email protected] (or) [email protected] #clinicaltrailsmanager #clinicaltrails #clinicaljobs #trailsmanager #clinicaldevelopment #trails #clinicalsupplies #wearehiring #hiringnow #jobforyou #joboffers #jobalert #joinwithus #joinourteam #lifesciencesjobs #katalysthls FDACenters for Disease Control and PreventionThe National Institutes of Health

Clinical SAS Programmer - Cambridge, MA Katalyst HealthCares & Life Sciences Overview: Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences. Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer’s guide, annotated CRFs) conforms to SOPs and to regulatory specifications. Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc. Contact: [email protected] (or) [email protected] #clinicalsas #sasprogrammer #sdtm #adam #sas #sasdeveloper #programmer #wearehiring #hiringnow #joinourteam #joinwithus #jobalerts #jobforyou #lifesciencesjobs #katalysthls FDACenters for Disease Control and PreventionThe National Institutes of Health

Manufacture Engineering - Weirton,?West?Virginia Katalyst HealthCares & Life Sciences Overview: Equipment commissioning reports and approval documentation. Planning and process documentation for operations. Safety and quality documentation. Line and equipment design. FAT plan and execution for assigned lines/equipment. Technical specifications/requirements for required equipment and services bids and technical review of supplier proposals. Contact: [email protected] (or) [email protected] #manufactureengineering #manufacture #engineering #engineeringjobs #wearehiring #hiringnow #joboffers #jobforyou #jobalert #joinourteam #joinwithus #lifesciencesjobs #katalysthls FDACenters for Disease Control and PreventionThe National Institutes of Health

Validation Engineer - Remote Katalyst HealthCares & Life Sciences Overview: Must have 15+ years of experience in GxP validation testing on pharmaceutical domain both manual and automation testing on onsite/offshore deliverable model handling with multiple applications. Experience in test effort estimation & resources planning across all the projects. Responsible for demand/capacity planning, resource management, stakeholder management. Experience in writing/enhancing of Test Plan, Test Strategy defining of in scope, out scope, testing approach, project milestone, Risks and mitigation etc. As an onsite Test Lead managing of offshore testing team on entire validation testing life cycle on test planning, Est cases design, test execution and defect management activities. Contact: [email protected] (or) [email protected] #validationengineer #validation #engineeringjobs #wearehiring #hiringnow #jobforyou #joboffers #jobopenings #jobalert #joinwithus #joinourteam #lifesciencesjobs #katalysthls FDACenters for Disease Control and PreventionThe National Institutes of Health

Sr Quality Engineer - Philadelphia, PA Katalyst HealthCares & Life Sciences Overview: Identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups such as Manufacturing, Quality Control, IT, Engineering and Validation. Supporting the oversight of Data Integrity and Computer System Validation efforts, system lifecycle and improvements. Supporting #cGMP quality improvement efforts at #iCTC (Philadelphia, PA) and in remote facilities such as #IOVA-A (Philadelphia, PA) and the Tampa Labs (Tampa Bay, FL). Creating and maintaining company documentation, such as quality manuals, and quality procedures. Applying good manufacturing practice and observing that it is being adhered to. Contact: [email protected] (or) [email protected] #srqualityengineer #qualityengineer #quality #engineeringjobs #wearehiring #hiringnow #jobforyou #jobalerts #joinourteam #joinwithus #lifesciencesjobs #katalysthls FDACenters for Disease Control and PreventionThe National Institutes of Health

Regulatory Affairs Specialist - Tampa, FL Katalyst HealthCares & Life Sciences Overview: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. Evaluate risk of proposed regulatory strategies; may offer solutions. Reviews proposed labeling for compliance with applicable US and international regulations. Contact: [email protected] (or) [email protected] #regulatoryaffairs #regulatory #wearehiring #hiringnow #jobforyou #jobalert #jobopenings #joinwithus #joinourteam #lifesciencesjobs #katalysthls FDACenters for Disease Control and PreventionThe National Institutes of Health

Senior Programmer - Remote Katalyst HealthCares & Life Sciences Overview: The senior programmer position will be responsible for manipulating large databases and generating reports to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS and SQL programming skills and the ability to implement complex logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience building patient cohorts and evaluating patient healthcare events in large databases and using observational research methods such as epidemiology and statistical methods is strongly desired. Strong communication, time management, enthusiasm and documentation skills are essential in this home-based position. Bachelor's degree in computer science, Statistics, Mathematics, or other subject with high statistical content. Contact: [email protected] (or) [email protected] #seniorprogrammer #programmer #database #sas #sql #statistics #wearehiring #hiringnow #jobforyou #jobalert #joboffers #joinwithus #joinourteam #katalysthls FDACenters for Disease Control and PreventionThe National Institutes of Health