Verista

Verista is a specialized company focused on providing quality assurance and validation engineering services, along with expertise in pharmacovigilance. They utilize advanced technologies to ensure compliance and safety in various sectors.

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🔥 SAS Analytics Administrator / Lead Information Systems Engineer - 5224

Posted 2024-11-07

📍 North Carolina, United States

🧭 Full-Time

💸 114730 - 173000 USD per year

🔍 Biopharmaceutical industry

Bachelor's Degree in sciences or engineering required; advanced degrees preferred.
10+ years of industry relevant experience.
Demonstrated experience with R&D Clinical applications, such as Statistical Analysis software and clinical data analysis tools.
Proficient understanding of R&D clinical processes in the biopharmaceutical industry.
Outstanding verbal and written communication skills.
Strong understanding of regulatory frameworks.
Ability to work independently and adapt to changes.

Responsible for the implementation and support of technology and informatics systems and programs.
Support development, implementation, operation, and continuous improvement of Laboratory Operations, Clinical, Biostatistics and Data Management, Bioprocess R&D and Regulatory/Risk Management applications.
Report to the IT Director, R&D Systems.
Work with SAS Office Analytics, Electronic Trial Master File (eTMF), AWS, Electronic Lab Notebook (ELN), and other digital tools.

AWSLeadershipProject ManagementAgileBusiness AnalysisData AnalysisPeople ManagementProduct ManagementSAS EGSCRUMProject CoordinationCross-functional Team LeadershipAmazon Web ServicesData analysisCommunication SkillsAnalytical SkillsCollaborationProblem SolvingAgile methodologiesAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communicationMultitasking

Posted 2024-11-07

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🔥 Lead CQV Engineer - 5232

Posted 2024-11-07

📍 United States

💸 87780 - 121170 USD per year

🔍 Life Science

Previous experience working on the Med Safety system.

Hypercare of the Med Safety systems post go-live.

LeadershipProject ManagementProject CoordinationCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationAttention to detailOrganizational skillsTime ManagementWritten communication

Posted 2024-11-07

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🔥 Senior Business Analyst (Clinical Data Lake) / Sr Business Analyst - 5231

Posted 2024-11-07

📍 Cambridge, Massachusetts, United States

🧭 Full-Time

💸 80465 - 116843 USD per year

🔍 Pharmaceutical industry

Bachelor’s degree or equivalent in a science discipline or related field.
7-10 years of experience in pharmaceutical industry or related experience in implementing clinical solutions.
Working knowledge of clinical data systems like EDC, Clinical Data Management systems, and eCOA.
Experience managing requirements for AWS Cloud solutions.
Proficient knowledge of Quality Process Assurance/Compliance and 21 CFR Part 11 regulations.
Familiarity with Agile methodologies and tools such as JIRA and Confluence.

Responsible for planning and developing business requirement/user stories in support of DevTech Products.
Act as primary subject matter expert for Clinical Data Lake.
Author system support processes and operational procedure documents.
Draft and review UAT scripts with the Testing team.
Translate business requirements into user stories and supporting documents.
Support product owner in prioritizing product backlog.
Ensure compliance with regulatory requirements and manage projects independently.

AWSSoftware DevelopmentAgileJiraDocumentationCompliance

Posted 2024-11-07

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🔥 Staff Analyst (Offshore) - 5196

Posted 2024-10-25

📍 India

🔍 Life Sciences

Bachelor's Degree or higher required.
Proficiency in using Microsoft Office tools.
Excellent oral and written communication skills.
Understanding of the Life Sciences industry.
Understanding of concepts of a regulated industry.

Collaborate with clients and internal resources for project completion and perform analyst, data, CQV, and CSV tasks.
Participate in system testing phases and plan testing efforts with the team.
Draft, review, dry-run, and execute test scripts using various testing tools.
Lead team members and collaborate to resolve system issues/errors.
Prepare system test plans and deliverables for Computerized System Validation.
Create and review documents for Quality Management Systems projects.
Gather, create, configure data for new systems, and perform data analysis/cleansing.

LeadershipData AnalysisData analysisCommunication SkillsAnalytical SkillsCollaborationMicrosoft Excel

Posted 2024-10-25

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🔥 Senior Business Analyst (Veeva) / Business Architect - 5143

Posted 2024-10-24

📍 United States

🧭 Full-Time

💸 87780 - 134000 USD per year

🔍 Pharmaceutical industry

Bachelor’s degree or higher required.
7+ years of business analysis experience in the pharmaceutical industry required.
Solid understanding of Veeva Quality Docs systems, data, and processes required.
Experience implementing/validating Veeva Quality Docs capabilities required, with a strong understanding of SDLC deliverables.
Preferred: Strong understanding of system integrations, including the design and construction of integrations and data flow from source to target systems.

Facilitate working sessions with business end-user representatives, IT representatives, and vendors to update existing or draft new requirements resulting from process or configuration changes and enhancements.
Manage the review and approval cycles for requirements.
Participate in system and user acceptance testing (UAT) activities.
Develop system/user testing scenarios and checklists based on business processes and requirements.
Assist with updates to user training documentation such as Quick Reference Guides and User Guides.
Manage activities related to drafting, reviewing, and approving system SOPs and Work Instructions.
Review SDLC deliverables for completeness, accuracy, and applicability.
Participate in organizational change management and user adoption processes.
Perform and document gap analysis between systems/processes.
Contribute to authoring documentation such as Solution Implementation Plans and Summaries, Test Plans and Summaries, and Requirement Traceability Matrix.

Business AnalysisData AnalysisData analysisCommunication SkillsAnalytical SkillsCollaboration

Posted 2024-10-24

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🔥 Senior CSV Engineer (Polarion) / Senior Validation Engineer 2 - 5067

Posted 2024-10-15

📍 United States

🧭 Full-Time

💸 80465 - 121170 USD per year

🔍 Life sciences

A minimum of a Bachelor’s degree in an Engineering or Scientific field.
6-10 years of role relevant experience.
Demonstrated experience with Polarion or excellent ALM software experience.
Strong Lab Informatics experience, particularly with LIMS (LabVantage).
Excellent communication skills for client interactions.
Ability to work independently on tasks.
Experience authoring, editing, and executing validation documents.
Knowledge of FDA regulations, ISPE guidelines, and ISO standards.

Our team needs a senior level CSV Engineer with ALM experience, ideally with Polarion.
Handle projects from a technical and validation perspective, including calculation validations in LabVantage, instrument integration, JMP/Statistica integration, data migration from legacy systems, LIMS integration, and other related tasks.

Communication SkillsCollaboration

Posted 2024-10-15

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🔥 Quality Lead/ Lead Validation Engineer - 5122

Posted 2024-10-15

📍 United States

💸 87780 - 140220 USD per year

🔍 Life sciences

Bachelor's degree and relevant GxP work experience.
8-10 years of validation activities experience.
Proficiency in Microsoft Office applications.
Experience performing Quality Assurance functions related to Clinical Computerized Systems / Infrastructure.
Familiarity with FDA / MHRA regulations.
Knowledge of GAMP and Agile validation lifecycle methodologies.
Experience with computerized quality management systems.
Expertise in FDA regulations, ISPE guidelines, and ISO standards, including Good Documentation Practice.
Strong communication skills to interact with all levels of the organization.
Attention to detail and ability to work independently.

Support the QISM group at the Client, focusing on IT Infrastructure and Clinical Operations.
Work closely with operational functions to provide oversight of computerized system implementation, maintenance, and retirement.
Review and approve computerized system lifecycle documentation.
Provide expertise in Part 11/Annex 11, and data integrity to stakeholders.
Participate in system implementation teams to guide on validation strategy and lifecycle activities using a risk-based approach.
Identify and define high risk areas to focus on patient safety, product quality, and data integrity.
Consult with team members to ensure compliance and manage risks.
Participate in Periodic Review activities of Computerized Systems.
Support regulatory inspection preparedness as needed.

LeadershipProject ManagementAgileData AnalysisPeople ManagementQASCRUMProject CoordinationJiraCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaborationMicrosoft ExcelAttention to detail

Posted 2024-10-15

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Verista

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