Katalyst Healthcares & Life Sciences

Job Description:The Senior Quality Engineer is responsible for the quality safety and reliability of the clients products. This role requires expertise in supplier design manufacturing and software quality engineering. The engineer must demonstrate an understanding of consumables and More...

Job Description:The Data Manager Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Man More...

Job Description:Positions are available for both handling and collecting blood from horseshoe crabs and processing the blood in a laboratory setting. Selected workers will be trained in all SOPs and cGMPs as well as general aseptic processing and disinfecting techniques.Responsibiliti More...

Responsibilities:Perform core regional quality systems activities as assigned (e.g. revising procedures assisting in inspection readiness) following defined procedures.Develop improve and revise regional quality system SOPs.Conduct ongoing analysis and reporting of key quality and ris More...

Responsibilities:Contribute with your statistical expertise to the design and analysis of one or more clinical trials or the clinical development plan of one compound/program.Will closely collaborate with program partners and stakeholders to deliver on the statistical deliverables for More...

Job Description:We are seeking a motivated and innovative R&D Engineer to support the design development and testing of medical devices in compliance with FDA and ISO standards. The ideal candidate will work closely with cross-functional teams to bring new products from concept to More...

Responsibilities:Supports necessary regulatory activities required for product market entry.Preparation of regulatory submissions for Electrophysiology Mapping and Imaging devices to achieve departmental and organizational objectives.Review and approve engineering change orders for pr More...

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...

Job Description:The role will include managing OEM Packaging opportunities for distributed products and / or development of sterile and non-sterile case and tray packaging for spinal implants and instruments. This includes the Design History File documentation to support the developme More...

Job Description:Experienced Component Engineer with strong expertise in equipment and process validation including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ). Proven ability to manage component selection supplier coordination and More...

Roles & Responsibilities:7-10 years experience in Computer System Validation of SAAS systems and Cloud systems.Must have experience in Agile methodology and handled multiple releases in parallel.Has working experience in any one or two of the following domains Tool validation like 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...

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...