Katalyst Healthcares & Life Sciences

Job Description:We are looking for a Validation Specialist IV who will lead validation and compliance activities for computerized systems analytical instruments and enterprise software. This includes supporting system implementation upgrades administration and retirement while ensurin More...

Responsibilities:Preparing documentation for international regulatory registrations.Preparing technical documentation to compliant to MDD and EU MDR.Defining worldwide regulatory requirements are necessary for regulatory approval of products.Participating in cross functional teams as More...

Responsibilities:The Sr. SAS Programmer will be responsible for statistical programming for the clients clinical studies.In this role you will develop and validate SAS programs for data presentation analyses and provide programming support to project team members.Our Ideal candidate w More...

Responsibilities:Participate in the development of the CMC regulatory strategy for small molecules.These submissions include health authority briefing packages IND/CTA NDA and MAA regulatory filings.Prepare and review CMC submission documents registration dossiers health authority bri More...

Roles & Responsibilities:Hands on experience with AWS Cloud migration testing.Hands on experience in Database and migration testing strategies.Must have life sciences and GxP application testing experience.Experience in handling large programs with multiple applications.Must be ab More...

Roles & Responsibilities:Will be responsible to work in a team atmosphere on the production of medical equipment spare parts and accessories in accordance with quality specifications.Works within clearly defined SOPs and adheres to quality guidelines.High school diploma or equival More...

Job Description:The Senior Validation Engineer will serve as a subject matter expert in validation leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning execution and continuous improvement of validation proc More...

Job Description:We are seeking a dedicated MES Support Specialist to provide 24/7 shop floor support including nights and weekends. This role is critical in supporting MES (Manufacturing Execution System) operators resolving incidents in real-time and ensuring uninterrupted production More...

Job Description:The Senior Quality Engineer is responsible to represent the quality engineering function to develop and execute the strategy to organize direct and report on all supplier quality-related activities for design and manufactured items made for the AST stapling business pl More...

Job Description:The Manufacturing Services Associate I is responsible for supporting all cGMP manufacturing production suites. They support the production groups by ensuring the suites are appropriately stocked with raw materials and consumables assemble and autoclave assemblies for u More...

Responsibilities:Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufact More...

Roles & Responsibilities:A minimum of four (4) years of relevant work experience.Hands on production line experience with validations.NC/CAPA root cause analysis FMEAs NPI Design Control Supplier Quality medical device.Someone already experienced with J&J would be preferred fo More...

Job Description:Bioresearch Centre is seeking a dedicated and talented full-time contractor for the position of Biologist I or II to join the Immunology Discovery Dermatology team. The role involves the design and execution of in vitro and ex vivo pharmacology experiments aimed at def More...

Responsibilities:Technical expert that will independently investigate identify develop and optimize new methods/ techniques to address critical project needs.Continuously seek to improve existing laboratory methods and processes.Read and adapt literature to accomplish assignments.Demo More...

Responsibilities:Develop implement and maintain software quality assurance processes for non-product software used in medical device development.Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software.Support audits and i More...

Job Description:Perform SCF operations maintaining product quality and production levels. Work as member of a team for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning/sanitizing. Monitor machine f More...

Responsibilities:Design code and test SAS programs used to generate CDISC SDTM & ADaM domains and tables listings & figures outputs.Perform analyses defined in the statistical analysis plan as well as ad hoc analyses as requested.Validate CDISC SDTM and ADaM data sets by using More...

Responsibilities:The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control and More...

Responsibilities:Create new 3rd party supplier documentation including design specifications labelling design drawings etc. for peritoneal dialysis disposable sets.Create modify and maintain design history files.Perform change control assessments.Work closely with project manager and More...

Responsibilities:Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.Review CRFs to ensure alignment with protocol; lead and More...