Katalyst Healthcares & Life Sciences

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...

Responsibilities:Design Verification Support:Review and support design verification protocols and test reports.Ensure compliance with internal design verification design control equipment control and risk management procedures.Assist cross-functional teams to complete design verificat 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...

Responsibilities:Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience.Knowledge of Design History file Device History Record and Device Master Record documents.Proficiency in Project management and execution.3-6 years of experience in DHF gap analysis / rem More...

Job Description:This section focuses on the main purpose of the job in one to four sentences.Technical lead for DHF structure within sustaining engineering for disposable medical devices.Responsibilities:This section contains a list of primary responsibilities of this role that accoun More...

Job description:The Medical Writing Word Processing Coordinator is responsible for formatting proofing and completion of Clinical Protocols Clinical Study Reports Investigators Brochures and other related clinical regulatory documents. Provides document formatting support to Medical W 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:The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic results-oriented and experienced Quality Assurance Specialist to join our organization as a Remote Worker.The candidate will be responsible for supporting the More...

Responsibilities:Manage end-to-end delivery of data management services concurrently for single/multi-service projects with little-to-no guidance ensuring quality deliverables on time and within budget to customer satisfaction.Provide comprehensive data management expertise to Clinica More...

Responsibilities:Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience.Bachelor of Engineering / Diploma in Mechanical or equivalent.Knowledge of Design History file Device History Record and Device Master Record documents.Proficiency in Project management a More...

Job Description:This position assists in the establishment implementation and maintenance of programs crafted to assure control of processes and products toward established standards of quality. The position uses problem solving techniques to increase quality and efficiency within the More...