Katalyst Healthcares & Life Sciences

Responsibilities: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 المزيد...

Job Description:This is what you will do:The Quality Events Specialist is a member of the Central Quality Systems and Compliance (CQSC) team. This position will support the execution of the Quality Management System.Responsibilities:Laboratory Investigation Record Quarterly Trending.G المزيد...

Job Description:We are seeking a Logistics Sampling Associate to support night shift operations within our Logistics department. The associate is responsible for sampling and handling incoming raw materials maintaining cleanroom standards and ensuring compliance with cGMP and SOPs. Th المزيد...

Job Description:As part of the sustaining engineering team you will be responsible for design changes for medical device products such as hospital beds and equipment. The engineering design changes may be related to design improvements new compliance requirements or supply chain suppo المزيد...

Job Description:The Finishing Support Associate helps with assembling kits preparing packaging materials and supporting finishing area activities. This role follows safety and quality procedures in a clean manufacturing environment.Responsibilities:Assemble kits and screen product com المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...