Clinical Trial Manager - Madison, NJ - KatalystHLS.com

Knowledge of drug development and FDA GCP/ICH regulatory guidelines. Proficiency with and ability to utilize software applications that support Clinical Operations: Microsoft Word, Excel, PowerPoint; Adobe Acrobat, EDC systems, etc. Clinical trial management system (CTMS) background is a plus.

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Regulatory Science project Manager - San Francisco, CA -KatalystHLS.com

Serves as a strategic partner to the Global Regulatory Leaders (GRLs) and/or Filing Team Leaders, work with the cross-functional global filing team members to define regulatory filing strategy, convert the strategy into an executable plan, and facilitate flawless execution of the plan to enable successful global filings and Health Authority interactions

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Senior Verification & Validation Engineer -KatalystHLS.com

Overview: Ability to learn how to Operate Flow Cytometer. Follow Software Verification procedures. Record SW verification results. Follow detailed instructions. Hands on experience with Verification & Validation of Hematology products testing Should be able to work in Agile envirnoment Assess the requirements, prepare test environment, feasibility and identify test scenarios Should write the test stratergy Should have knowledge on FDA Guidelines

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Junior SAS Programming analyst - South Plainfield, NJ - KatalystHLS.com

Roles & Responsibilities: Supports Optum in using SAS to code production level robust, repeatable and well documented SAS programs to extract health insurance claims and health care operational data Independent creation of technical specifications, design and architecture Production of accurate results to support contractual results and performance guarantees (PGs) for high visibility clients Creates data extracts, cleanses data and produces normative information for calculation Data acquisition and methods vary greatly by client, support both standard and non-standard methods Analyze and manipulate large sets of healthcare data Work on SDTM, TFL & ADAM Specification.

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Senior Statistical Programmer - Boston, MA - KatalystHLS.com

Senior Statistical Programmer - Boston, MA - KatalystHLS.com Responsible for study closeout and providing submission-ready statistical programming deliverables to the client. Ensure compliance of CDISC SDTM and ADaM datasets by running OpenCDISC validator and documenting issues. Generate and review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide. Ensure review of study documents such as Protocol, CRF, and SAP.

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Instrument Validation Specialist - Menlo Park, CA - KatalystHLS.com

Instrument Validation Specialist - Menlo Park, CA - KatalystHLS.com Quality Control Software Validation and Instrument Qualification, Perform analytical computerized instrument and software validation, spreadsheet validation and validation periodic review to support a variety of the labs within QC organization.

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Senior Clinical Supplies Management Specialist - Home Based - KatalystHLS.com

Senior Clinical Supplies Management Specialist - Home Based - KatalystHLS.com Independently coordinates clinical supply activities for clinical studies in support of development programs. These activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labelling contracts, and forecasting and ordering supplies. Must coordinate the efforts of Clinical Trial Supplies Packaging with Clinical Supplies Manufacturing, Clinical Research, Pharmaceutical Development, Quality Assurance. Regulatory Affairs with the objective of establishing a plan to have clinical supplies available within the agreed time frame. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.

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Regulatory Affairs Associate - Stamford, CT - KatalystHLS.com

Regulatory Affairs Associate - Stamford, CT - KatalystHLS.com Review beauty care formulas and raw materials for compliance with US and Canadian regulations. Review beauty care artwork for compliance with US and Canadian regulations. Support regulatory affairs and product safety team.

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Clinical Trail Management Associate - Foster City, CA - KatalystHLS.com

Clinical Trail Management Associate - Foster City, CA - KatalystHLS.com Supports Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in ensuring the assigned clinical study(ies) are run on time and to budget. Completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all company policies and procedures. Periodic review of protocol deviations. Database lock activities (interim or final lock). Regional study drug management: track shipping or storage site temperature. excursions. Regional trial master file management (TMF): ensure all documents are appropriately filed in the TMF.

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Validation Consultant,Laboratory Systems - Woodway, TX - KatalystHLS.com

Validation Consultant,Laboratory Systems - Woodway, TX -KatalystHLS.com Responsible for performing duties related to computer systems validation project management. Includes attending status meetings, strategy meetings and other required meetings as well as maintaining the validation timeline and status for validation projects.

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Validation Consultant,Laboratory Systems - Woodway, TX - KatalystHLS.com

Validation Consultant,Laboratory Systems - Woodway, TX - KatalystHLS.com

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Pharma chemist III - Irvine, CA - KatalystHLS.com

Pharma chemist III - Irvine, CA - KatalystHLS.com The ideal candidate is expected to maintain current knowledge and understanding of GMP requirements and practices, familiar with analytical techniques such as HPLC, UPLC, GC, dissolution, particle size distribution, physical appearance, viscosity, rheometry and drug delivery system release profiles for drug products and/or drug substances.

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Clinical Trail Management Associate - Foster City, CA - KatalystHLS.com

Clinical Trail Management Associate - Foster City, CA - KatalystHLS.com Supports Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in ensuring the assigned clinical study(ies) are run on time and to budget.

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Instrument Validation Specialist - Los Gatos, CA KatalystHLS.com

Instrument Validation Specialist - Los Gatos, CA KatalystHLS.com Write validation protocols and final reports and function as a validation SME. Conduct computer and software validation, validation periodic review, and Validation Status List management.

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Computer System Validation Engineer - Anaheim, CA - KatalystHLS.com

Computer System Validation Engineer - Anaheim, CA - KatalystHLS.com Possess system quality and compliance knowledge of GxP regulations (21 CFR Part 11, Annex 11 & GAMP5) Hands-on authoring/ review/ approval of computer system validation deliverables. Author Validation Plan, Design Specification, IQ, OQ & PQ Protocols, Traceability Matrix and Validation Summary Reports for assigned project

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Life Science IT Infrastructure Qualification Lead - Mesa, CA - KatalystHLS.com

Life Science IT Infrastructure Qualification Lead - Mesa, CA - KatalystHLS.com Leads the effort to manage, and/or maintains qualification of the GxP infrastructure components such as security devices/tools, servers, networks, data center equipment. Perform GxP assessment and create Qualification Plan

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Data Integrity Analyst - Acton, MA - KatalystHLS.com

Data Integrity Analyst - Acton, MA - KatalystHLS.com The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc. Upon completion of their review, the individual will also be responsible for the release of equipment back to GMP manufacturing

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Pharma Validation Engineer - Rye, NY KatalystHLS.com

Pharma Validation Engineer - Rye, NY KatalystHLS.com Develop and manage project technical documentation for SDLC requirements during computer system implementation projects including developing validation approach, validation planning, technical system process flows, technical installation, development and verification documentation (IQ/OQ/PQ).

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CMC Regulatory Affairs Associate - Foster City, CA - KatalystHLS.com

Coordinating the planning, preparation and submission of global regulatory CMC-related submissions for clinical and commercial products such as: post approval variations, Marketing Application(s), Annual Reports, Clinical Trial Applications, and amendments. Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements. Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time. Performing regulatory research and drafting reports summarizing regulatory requirements.

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Validation Specialist - Cambridge, MA - KatalystHLS.com

Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system Review validation deliverables for projects which are contracted to third party suppliers

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Validation Analyst - Bedford, MA - KatalystHLS.com

Approve system life cycle deliverables (SDLC} and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities. Represent IT Quality on cross-functional teams with IT R & D in support of SDLC activities. Consult on the authoring and conformance of validation-related deliverables and activities in regards to corporate SOPs and current regulations. Provide guidance, training and support to IT personnel in their validation efforts, to ensure compliance.

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Validation Engineer III - Ithaca, NY KatalystHLS.com

Validation Engineer III - Ithaca, NY KatalystHLS.com Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestions on improvements based on recent technical knowledge and voice of customer. Act independently and communicate with technical and clinical team members.

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Regulatory Affairs Specialist - Santa Ana, CA KatalystHLS.com

Regulatory Affairs Specialist - Santa Ana, CA KatalystHLS.com Coordinate and assist in the maintenance of licenses and authorizations for existing products (e.g., US PMA, International Registrations and Dossiers, updates to technical files), engineering and device changes requests. Participates in cross-functional project teams

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Software Validation Engineer - Santa Ana, CA KatalystHLS.com

Software Validation Engineer - Santa Ana, CA KatalystHLS.com Experience of taking part in Risk Management activities as appropriate Can perform computerized system category assessment, Risk assessments, 21CFR Part 11 assessment\'s and complete system development and implementation following established system change control practices.

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Validation Engineer III - Ithaca, NY KatalystHLS.com

Validation Engineer III - Ithaca, NY KatalystHLS.com Communicate expectations and receive deliverables from cross functional team members (Manufacturing, R&D, and medical). Contribute to the planning and execution of components of the development process, which apply to process / product revision or enhancement or a defined piece of a larger project.

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Veeva Vault Administrator - South Plainfield, NJ 07080 KatalystHLS.com

Veeva Vault Administrator - South Plainfield, NJ 07080 KatalystHLS.com Primary system administrator for the day-to-day administration of Veeva Vault. Work with the vendor for any major issues/bugs in the application.

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Senior Qa Validation - Edison, NJ KatalystHLs.com

Senior Qa Validation - Edison, NJ KatalystHLS.com Excellent technical writing skills Understanding of Agile Change Management Process Good Understanding of GAMP 5 CSV Model of Validation Understanding of Agile Change Management Process Created all the Validation Artifacts for GxP environment Work on creation of SOPs

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Clinical Study Manager - Menlo Park, CA ,KatalystHLS.com

Clinical Study Manager - Menlo Park, CA , KatalystHLS.com May assist in reviewing clinical study protocols, informed consents, case report forms, Monitoring plans, clinical study reports and other study-related documents Assists in development of clinical studies and respective documents for company products

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Regulatory Engineer - Pleasanton, CA

RegulMedical device - Regulatory experience in electro mechanical & disposable products Experience in Medical device - R&D (Mechanical) Experience in Medical device - Risk Management (Mechanical background)atory Engineer - Pleasanton, CA

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Quality Control Analyst - Lexington, MA

Quality Control Analyst - Lexington, MA Experience Working in R&D or a lab type setting. Industry experience Preferred. 0-2 years GMP knowledge.

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Principal Validation Engineer - San Antonio, TX - KatalystHLS.com

Responsible for performing duties related to computer systems validation project management. Includes attending status meetings, strategy meetings and other required meetings as well as maintaining the validation timeline and status for validation projects. Manages the activities of validation consultants utilized to assist in the implementations.

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Clinical Compliance Specialist - Exton, PA- Katalysthls.com

Under the direction of the Clinical QA Lead, the position is responsible for leading the QA activities of assigned programs being managed by the Clinical Development organization. Primary responsibilities for this role are to provide batch record review, review deviations, CAPA, assist with QTA\'s and release of Clinical Supplies.

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Commissioning Qualification And Validation Engineer - Allendale, NJ

Commissioning Qualification And Validation Engineer - Allendale, NJ

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