Katalyst Healthcares & Life Sciences

Roles & Responsibilities:GMP Experience.Minimum 8 years in a GMP-regulated biopharmaceutical environment.Quality Assurance Experience .At least 2 years specifically in a QA role.QA Compliance Knowledge.Strong knowledge of QA Compliance systems including.Quality Management Review ( 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...

Job Description:We are seeking to add top talent to our Materials Support team. The Material Handler performs operations of the Supply Chain/Materials Management department with awareness and knowledge of the various areas of the operations in Goods Receipt Goods Issue Warehousing Inv More...

Responsibilities:Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice Real-Time Reviews 180-Day Supplements Annua 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 More...

Responsibilities:The Senior Manager Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring compiling and management of CMC sections for global regulatory filings.This role requires a strong understanding of the drug development More...

Job Description:We are seeking a Cleaning Validation Engineer with hands-on experience in the startup and validation of clean utility systems such as Water Generation Systems (WFI/RO/DI) Clean Steam Systems Process Gas/Air Systems Distribution Systems Storage Tanks and CIP/COP Systems More...

Job Description:We are seeking a Product Development Tech for our Brea CA facility. This person contributes to the completion of routine technical tasks and develops solutions to routine technical problems of specified scope. Their contacts are primarily with immediate supervisors pro More...

Responsibilities:Support clinical trial applications submitted via Clinical Trial Information System (CTIS) uploading documents Qin documents uploaded to ensure accurate categorization.Track CTIS application details to compile metricsMonitor CTIS notifications received due dates and t More...

Responsibilities:Effectively designs and codes SAS programs using BASE/SAS SAS/STAT SAS/GRAPH and SAS MACROS for assigned clinical projects(s).Produces and delivers CDISC and regulatory compliant SDTM and ADaM standard datasets.Creates and validates tables figures and listings (TFLs) More...

Job Description:The Senior Engineer External Manufacturing and Supplier Quality provides strategic and tactical support to External Manufacturing by executing quality activities such as base business support and nonconformance root cause investigation to maintain and improve customer More...

Responsibilities:Prepare and review CMC submission documents registration dossiers health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.Responsible for the global regulatory evaluation o More...

Roles & Responsibilities:Strong Experience with Test Method Validation and MSAs.Strong Risk Management Experience (Experience in Risk Documentation: Write review approve multiple quality records includes but not limited to: Design Files Risk Management files RPM P1 and P2 calculat More...

Job Description:The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11 EU Annex 11 and ISO 13485. This role ensur More...

Responsibilities:Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures.Develops protocols and associated reports while adhering to a change management process.Supports the execution of equipment qualifications and validation More...

Job Description:The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products.The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clini More...

Job Description:We are seeking a motivated and detail-oriented Associate Clinical Data Manager to join our Clinical Data Management (CDM) team. This is an entry-level position ideal for candidates looking to start a long-term career in clinical research and data management. In this ro More...

Responsibilities:Support and advise cross-functional teams and communicate APAC regulatory requirements and challenges effectively to meet project needs and company objectives.Oversee and direct the development of priorities timelines receipt of technical information from appropriate 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...

Responsibilities:Lead and execute CSV activities across GxP-regulated systems (LIMS MES ERP etc.Author and maintain validation deliverables: URS FS DS IQ OQ PQ and traceability matrices.Ensure systems comply with 21 CFR Part 11 EU Annex 11 and GAMP 5.Support system implementations upg More...