Katalyst HealthCares & Life Sciences

Job Title: Engineer I-Quality Location: Austin TX Katalyst HealthCares & Life Sciences #Overview: - The Manufacturing Quality, Quality Engineer I (#QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of #GMP compliance. - Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with #GMP compliance. - Conducts real time batch record reviews in assigned areas. - Reviews equipment logbooks and evaluates adjustments for impact to product quality. - Create, review, and revise procedures and assist with #CAPA investigations as applicable. - Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required. - Strong oral/written communications skills and leadership skills required. - Capable of rapidly absorbing technical data and the ability to apply this knowledge to a pharmaceutical manufacturing environment. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization #CAPA MHR https://lnkd.in/dETaeHwE

Job Title: Project Manager Location: Skaneateles NY Katalyst HealthCares & Life Sciences #Overview: - Lead cross functional teams in complex engineering assignments, on a project-by-project basis. May cross traditional product lines. - Independently plan, execute and direct cross functional engineering projects, that may cross traditional product lines. - Diverse new approaches to problems encountered through adaptations and modifications of standard engineering principles. - Manage projects on a cross functional basis, including direct supervision of team members. - Manage the project costs (all financial aspects) of product development. This will include capital expenditures and cross functional expenses. - Identifying and resolve complex problems, including the development of new design experiments, without supervision. - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. - Good communication skills with matrix management experience required. Independent judgment in the evaluation, selection and adaptation of various engineering techniques required. - B.S. and 8-10 years' experience, 2 - 5 years of matrix mgt. experience. Thorough, up to date knowledge of multiple disciplines required. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention #CAPA MHR https://lnkd.in/dUYWsXw8

Job Title: Supplier Quality Engineer Location: Marion, NC Katalyst HealthCares & Life Sciences #Overview: - Follow up on supplier audits to demonstrate supplier controls required by #FDA #CFR 820, #ISO 13485 and ISO 9000. - Verify supplier files are maintained and documented appropriately. - 5+ year qualifying experience, including previous experience with quality auditing, specifically supplier audits. Excellent documentation, communication and excellent problem-solving skills desirable. FDA The National Institutes of Health ISO - International Organization for Standardization MHR #CAPA Centers for Disease Control and Prevention https://lnkd.in/dJrADdaF

Job Title: Quality Validation Engineer with Electrical Motor Location: Peoria, IL Katalyst HealthCares & Life Sciences #Overview: - Bachelor’s degree in an accredited Engineering, Computer Science, or Materials Science curriculum. - Experience with electric drive systems and/or components, with focus on electric motor and generator. - Experience with structured #FMEA & #DVP&R process. - Experience with #NPI Issue resolution process. - Experience with #CAT #NPI Programs and Processes. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/dcshyFWn

Job Title: Computer System Validation Engineer Location: Santa Monica, CA Hybrid (3 days onsite 2 days remote) Katalyst HealthCares & Life Sciences #Overview: - Compliance – quality oversight - Experience Level – 8-12 years max Looking for someone for CSV work in Santa Monica in support of cell therapy lab equipment. - Proficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects. - Bachelor’s degree in IT or Computer Science. - Familiarization with ITIL/GAMP5 Validation Lifecycle - 21 CFR, EU regulations - Take Quality ownership, participate in cross functional team discussions, provide quality guidance/decisions for the projects that includes New implementation, Enhancements, Quarterly releases, etc. - Participate and Drive System Assessments, review and approve the project deliverables including plan, test scripts, execution and its outcome, reports, traceability. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/dZgnjh2s

Job Title: Validation Engineer Location: Sterling, VA Katalyst HealthCares & Life Sciences #Overview: - Lead deviation investigations to identify root causes and implement effective corrective and preventive actions (#CAPAs) to prevent recurrence. - Ensure timely initiation, documentation, and closure of deviation investigations, following internal procedures and regulatory guidelines. - Review and assess the impact of deviations on product quality, safety, and regulatory compliance. - In-depth knowledge of #cGMP regulations, #ICH guidelines, and industry best practices. - Strong understanding of pharmaceutical manufacturing processes and quality systems. - Experience in conducting investigations, root cause analysis, and implementing #CAPAs. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/d23F3szK

Job Title: Senior Quality Engineer Location: Wilmington, NC Katalyst HealthCares & Life Sciences #Overview: - The Senior Quality Engineer provides comprehensive engineering support to the manufacturing plant, focusing on process optimization, risk management, defect prevention, and validation. The role involves ensuring compliance with #GMP/QSRs and applicable standards related to product and process validation. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/dDjU9WDz

Job Title: Regulatory Affairs Specialist Location: North Chicago, IL Katalyst HealthCares & Life Sciences #Overview: - Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the #FDA or other worldwide regulatory agencies to various international affiliates. - Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission database and file systems. - Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel May interface directly with #FDA and other regulatory agencies. - Supports the product release process by creating #GTS licenses or reviewing and approving requests for product release. - Reviews protocols and reports to support regulatory submissions. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/dXbfBwnf

Job Title: Regulatory Affairs Specialist Location: Norwood, MA Katalyst HealthCares & Life Sciences #Overview: - MUST HAVE #IVD (In-vitro Diagnostics) & Support the #IVDR project team to investigate and resolve issues related to equipment failures, system deficiencies, deviations, and equipment troubleshooting. - Support authoring quality systems records such as deviations, change controls, and #CAPAs as Required. - Monitor and communicate method lifecycle (acquisition, qualification/validation implementation) timelines using project management tools. - Ordering supplies and maintaining inventory for equipment consumables/accessories. - cross-functional matrix environment (#QC, #QA, Validation, Digital, Vendors) to ensure equipment is serviced on time. - Experience with #CTU (Controlled Temperature Units) and equipment calibration. - Proficiency with Microsoft Office Programs FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/dqeqqC2M

Job Title: Clinical Data Manager Location: Menlo Park, CA Katalyst HealthCares & Life Sciences #Overview: - Leads all clinical data management activities for assigned clinical studies assuring all timelines are met with best quality. - Responsible for overseeing creation and approval of #DM study documentation by vendors/CROs (i.e. #CRFs, completion guidelines, database specs, edit checks, data review plans, data transfer specifications, #SAE reconciliation plans, and external vendor data reconciliation plans). - Experience leading all #DM functions for clinical studies including global studies including but not limited to data management plans, edit specifications, utilizing data dictionaries, electronic data transfers, data quality reviews and reporting. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization #CAPA MHR https://lnkd.in/ddKFYFww