Katalyst Healthcares & Life Sciences

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 المزيد...

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 المزيد...

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) المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

Roles & Responsibilities:CLINICAL R&D Experience is a must.AI experience is a plus!Clinical R&D Background:Experience of working in a Clinical R&D organization or a division of a large pharma company.Support implementation of systems used in pharmaceutical R&D such المزيد...

Roles & Responsibilities:Provides real-time support for manufacturing issues on the production floor.Leads investigations into quality events using root cause analysis.Collaborates with subject matter experts to determine immediate actions and containment strategies.Determines roo المزيد...

Job Description:The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing designing and implementing high-priority analytical strategies clinical oversight and initiatives. The team is a high-profile high-impact team that works with PP المزيد...

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 المزيد...

Job Description:We are seeking a highly motivated and collaborative Associate Scientist to join our Dermatology Immunology group within Discovery Research. This individual will support early- through late-stage discovery programs by supporting complex in vitro experiments to study ski المزيد...

ResponsibilitiesFollow all company safety rules regulations and job safety analysis.Must complete plant lock out procedures and key interrupt.Fill and operate shelf carton erector and clear minor jams.Responsible for quality of product including but not limited.Discarding obviously de المزيد...