Katalyst Healthcares & Life Sciences

Responsibilities:Work with Supplier functions to develop PFMEA Control plans and statistical plans (Cpks). Ensures that project and/or process control documentation is compliant with requirements and/or contract.Experience advancing Zero Defect culture utilizing advanced Quality tools More...

Job Description:This position focuses on assisting with analysing data and deriving insights from clinical and safety data sources to generate evidence and support decision making across the organization. The Associate will leverage a variety of analytics More...

Responsibilities:5 yrs of experience in Statistical Programming using SAS preferably in UNIX environment supporting clinical trials data analysis. Enterprise Guide experience is a plus.Solid CDISC Standards knowledge and solid Adam programming experience. Oncology TA experience is pre More...

Job Description:The Global Compound Logistics and Operations organization (GCLO) within the company manages the inventory dispersal and logistics of biological and chemical entities used by Discovery and Development scientists for all aspects of Company drug discovery.Seeking a highly More...

Roles & Responsibilities:Electronic Mechanical background.Demonstrated QMS experience along with documentation.Supplier Quality Management Coordination and timely interaction.V&V protocols & reports.First Article Inspection experience.Once on boarded resources will undergo More...

Job Description:Equipment Validation Specialist exists to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements process parameters and global regulatory guidelines. The role provides Operations Quality Assurance and regulatory More...

Responsibilities:Follow all company safety rules regulations and job safety analysis.Must complete plant lock out procedures and key interrupt.Fill and operate shelf carton erector and clear minor jams.Responsible for quality of product including but not limited.Discarding obviously d More...

Responsibilities:Analytical chemist responsible for commercial and pipeline small molecule development within Product Development Science & Technology Operations.Perform routine analytical chemistry tests competently and independently to generate reliable and consistent results.Le More...

Responsibilities:Perform routine analytical testing to support quality control testing of pharmaceutical products.Some data interpretation required.Coordinate testing of samples and input data into computer application.Should have good laboratory skills preferably in pharma/biotech.Ex More...

Job Description:We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment.The role focuses on ensuring compliance with FDA regulations (21 CFR Part) GAMP5 metho More...

Job Description:CSV Analytical and Enterprise Validation specialist IV will lead validation activities including but not limited to software updates new system introduction Administration of systems and applications and decommissioning activities as appropriate. This person will work More...

Responsibilities:Support the Lead Data Manager across one or more clinical studies.Reviews protocols for appropriate data capture including electronic (eCRF) design.Support CRF design review and validation of clinical database.Provide expertise and support oversight of database set-up More...

Responsibilities:Proactively investigating identifying and implementing best-in-class quality engineering practices.Providing focused quality engineering support and assuming responsibility for timely and effective coordination and execution of assigned development project activities. More...

Responsibilities:Review protocols and comply with study-specific activities.Communicates in an appropriate and professional manner with study subjects and unit personnel.Maintain accurate and complete source data.Perform study protocol related activities i.e. phlebotomy sample process More...

Responsibilities:Perform data manipulation analysis and reporting of clinical trial data.Develop and maintain department/system-level macros.Create and review SDTM and Adam specifications.Create and validate SDTM data sets.Create and validate analysis data sets.Create and validate pat More...

Job Description:The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing designing and implementing high-priority analytical strategies clinical oversight and initiatives. The team is a high-profile high-impact team that works with PP More...

Responsibilities:Your primary responsibilities will be to effectively organize and lead cross-functional project teams using your project management skills .Using your strong planning organization communication and collaboration skills you will lead a diverse scope of projects with li More...

Job Description:Seeking a hands-on Quality Engineer with experience in medical and implantable devices to support and enhance its product assurance and regulatory compliance programs.This role focuses on ensuring the quality and integrity of new and existing products in accordance wit More...

Job DescriptionThe Program Manager for the Meetings & Events (M&E) Centre of Excellence will lead the planning execution and oversight of Project Genesis across multiple OUS affiliates. The role involves coordinating with crossfunctional teams to align project objectives manag More...

Responsibilities:Coordinate and execute electronic document changecontrol activities in compliance with internal procedures.Work directly with the DST Team Lead for training and task guidance taking on increased responsibility over time.Ensure accuracy in document processing tasks inc More...