Katalyst HealthCares & Life Sciences

Job Title: Environmental Health & Safety Specialist 3 Location: San Diego, CA Katalyst HealthCares & Life Sciences #Overview: - Familiar with #DHS, #OSHA, #EPA, #RCRA, Air Quality, and Water Pollution regulations. - Prior experience problem-solving ergonomic safety concerns and conducting ergonomic evaluations in different work settings (Industrial, Warehouse, Materials Handling) is required. - Experience managing hazardous waste programs. - Minimum 5 years of related experience working in a warehouse, distribution center, or biotech or medical device manufacturing environment with safety and/or environmental responsibilities. - Bachelors' Degree Desired, safety or a related discipline strongly preferred. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization #CAPA MHR https://lnkd.in/dn_ji3fC

Job Title: CMC Regulatory Affairs Manager Location: Swiftwater, PA Katalyst HealthCares & Life Sciences #Overview: - Provides #CMC regulatory support and guidance to project teams for clinical development and post approval changes; defines #CMC regulatory submission strategies during development and post approval. - Experienced with clinical trial (IND/IMPD/CTA) and marketing applications (BLA/NDA/MAA) filing requirements including content requirement, technical writing, and tracking timelines. - Works with technical departments in R&D/Operations/Quality to develop high quality submissions. - Prepares and manages submissions to filings and supports review by regulatory authorities. - Liaises with #FDA and other regulatory authorities in written communication and participates in meetings on product development regulatory issues. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/dzt6WC2S

Job Title: Regulatory Affairs Specialist Location: Irvine, CA Katalyst HealthCares & Life Sciences #Overview: - Support the #IVDR project by revising the assigned technical files.  - Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity. - Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the technical file. - Each assigned technical file must be completed within a pre-defined timeline. - Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work. - Support the #IVDR labelling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization #CAPA MHR https://lnkd.in/dY45i9PM

#GlobalBiosimilarWeek Katalyst HealthCares & Life Sciences #Biosimilars provide a significant opportunity to expand patient access to essential medicines without sacrificing product quality. Data shows that when comparing a biosimilar to its FDA-approved reference product, there are no clinically meaningful differences in safety, purity, or potency. Like all biologics, #biosimilars are tested in accordance with the cGMP regulations enforced by the FDA. For more information about the quality, safety, and effectiveness of #biosimilars, view the new educational resource from FDA and US Pharmacopeia: https://lnkd.in/dPRTAbBR 🇺🇸 🎊 🎉 🧬 #KHLS

Job Title: CSV Implementation Specialist Location: Framingham, MA Katalyst HealthCares & Life Sciences #Overview: - Provide #CSV support for VEEVA #eQMS (Change Control, #CAPAs, Deviations) and initial #LIMS phase. - Contribute to Oracle #ERP phase 2 and Master Control #EBR implementations. - Support #CSV for Trace link and serialization software integrations. - Collaborate with teams to ensure smooth progression and compliance across projects. - Strong #CSV background, with experience in Veeva, Master Control, Oracle #ERP, and #LIMS. - Familiarity with SaaS applications and cloud-based environments. - Excellent soft skills for team collaboration. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention #CAPA MHR https://lnkd.in/dATFM2Ar

Job Title: Regulatory Affairs Associate III Location: San Clemente, CA Katalyst HealthCares & Life Sciences #Overview: - Drives projects forward and executes agreed upon strategies and plans with oversight. - Maintains awareness of applicable regulations. - Plans and organizes registration packages for device products. - Prepares registration packages in line with local regulatory requirements and guidelines. - Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. - Accurately describes these changes for ease of regulatory agency review. - Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. - May serve as a lead regulatory representative to an assigned product or project team. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization #CAPA MHR https://lnkd.in/dft5ekTy

Job Title: Medical Writing Word Processing Coordinator III Location: Lake County, IL Katalyst HealthCares & Life Sciences #Overview: - The Senior Word Processing Coordinator II is responsible for formatting, proofing, and completion of clinical protocols, clinical study reports, investigator brochures, summaries, and other related clinical documents.  - Provides regulatory document formatting support to the Medical Writing, Clinical, and Pharmacovigilance Teams, ensuring successful preparation of high-quality submission-ready documents.  - Ensures completion of work to meet multiple client deadlines.  - Ensures styles and formatting are consistent with defined eSubmission standards so that the documents created in MS Word correctly render to PDF. Proofreads documents for accuracy and consistency. - Coordinates and communicates with other word processing team members for consistency for all documents.  - Imports and routes documents in the submission system ensuring proper naming conventions and document properties. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention MHR #CAPA https://lnkd.in/d7-FCgzA

Job Title: QA CSV Specialist Job Location: Springhouse, PA Katalyst HealthCares & Life Sciences #Overview: - The candidate will play a pivotal part in ensuring the compliance and efficiency of computerized systems within the new facility, contributing to the successful implementation of our operations. - This role presents an exciting opportunity to be part of a dynamic team and make a significant impact on the quality and reliability of our systems in a cutting-edge environment. - Providing quality assurance support and oversight for System Development Life Cycle (#SDLC) deliverables of primarily - Laboratory Instrument Systems and secondary for Application Systems - Industry experience including computer system validation, System Life Cycle (#SLC), software validation, and/or Quality Assurance functions. FDA The National Institutes of Health Centers for Disease Control and Prevention ISO - International Organization for Standardization MHR #CAPA https://lnkd.in/eaS8B3qD

Job Title: Quality Engineer III Location: Plainsboro, NJ Katalyst HealthCares & Life Sciences #Overview: - Monitors, inspects, and evaluates products to ensure predetermined quality standards are met. Develops and updates testing-related documentation, including test cases, plans, and flaw-reporting procedures. - Performs Quality and technical review of Nonconformance investigations (#NCs) and #CAPAs within defined timeframes. Ensures investigations and root cause analysis are accurate and complete - Maintain an accurate log of Non-Conformances and #CAPAs activities. Tracks, follows-up and assists in the timely closure of #NCs/CAPAs. - CAPA and non-conformance experience required - Investigation experience required - Managing system - Bachelor's Degree is required. 7+ years of experience. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention #CAPA MHR https://lnkd.in/eP58RXau

Job Title: Validation Engineer Location: Medina, NY Katalyst HealthCares & Life Sciences #Overview: - 7+ years of experience in software validation within the #Pharma/Med Device space, specifically with #QMS and #PLM systems. - In-depth knowledge of validation methodologies and relevant regulatory frameworks (#FDA, #ISO). - Experience with #ERP systems and software integration, particularly in labeling processes. - Flexibility to travel as project demands require. FDA The National Institutes of Health ISO - International Organization for Standardization Centers for Disease Control and Prevention #CAPA MHR https://lnkd.in/dw4-6dU3