TrialScope is the global leader in clinical trial transparency and compliance. Our customers include 14 of the top 30 Pharmaceutical and Biotech companies in the world, including 7 of the top 10. Our tools and systems enable our customers to make clinical trial information accessible to the public, helping researchers and patients more easily locate the clinical trials most useful to them. Capabilities include seamless clinical transparency and integration with internal data services such as CTMS platforms. Our technology offers a fully validated SaaS platform hosted in a private cloud.

Enrich your skills while helping the life sciences industry become more transparent to the public. We are located in Jersey City, NJ across the river from New York City.

Our current job openings are listed below.

QA Validation Analyst

Description

Under general direction of the Director QA, Privacy & Compliance, the QA Validation Analyst supports the computer system validation process by ensuring alignment of operations with system requirements, corporate policies, industry standards, and applicable regulations. This individual will identify gaps in the software validation program, conduct effective CSV assessments, execute validation testing, defect resolution and complete validation deliverables. The individual should be a good team player with good communication. motivation, team building and mentoring skills with the ability to work independently and in rapport with Management, Business Analysts, Functional Leads and Project Managers....

Key Responsibilities

  • Assists in the development, planning and tracking of the validation of computer systems developed by the TrialScope Agile development teams
  • Expertise in all phases of an Agile based Software Development Life Cycle (SDLC) and Computer System validation (CSV)
  • Works with the project teams to develop validation strategies for projects and works closely with project managers and program managers to meet the deadlines
  • Provides leadership to the technical and business analysis team members to ensure compliance with system requirements, corporate quality standards, GDPR guidelines, Privacy Shield principlies, GxP requirements and FDA regulations (21 CFR part 11, Annex 11 and/or 21 CFR Part 820)
  • Maintains production computer systems in a regulatory compliant state, monitors all modifications or changes to systems or processes, initiates change control / revalidation as required and ensures a continual state of inspection readiness per the requirements of the Quality Management System (QMS)
  • Reviews and approves Validation Plans (VP), Qualification Protocols (IQ/OQ/PQ), Trace Matrices (RTM), Test Plans, Risk Assessments (RA), and Final Validation Summary Reports (VSR) by providing instructions and guidance for the creation of validation deliverables
  • Monitors the testing efforts of the IS/IT and business teams with regards to test coverage and test strategies
  • Guides the business and development staff to create thorough, accurate and comprehensive test scripts
  • Develops, maintains and executes validation audit test scripts, test metrics and generates reports for management use in determining project and applications validation status
  • Investigates, gathers and furnishes additional information about functional defects including log files, procedures to reproduce, etc., communicates concerns, and retains contact and continues discussion with the development staff as testing progresses to ensure test results are appropriate and meet validation needs
  • Performs post-execution audit reviews of test cases for completeness, accuracy, and adherence to policies and procedures
  • Provides technical decision making regarding validation strategies for complex projects
  • Maintain accountability for training validation test team on validation methods
  • Oversees overall document management for all validation deliverables including, but not limited to the deliverables called out in the SDLC SOP
  • All aspects of validation package contents
  • Assisting in the routing and approval process of documents
  • Archiving all CSV documentation
  • Assembles data for special software validation reports
  • Performs computer system regulatory compliance assessments for new programs/or products per policies and procedures.
  • Must be a Team player with the ability to work independently. Communication, motivation, team building and mentoring skills are required
  • Support Quality Assurance through consultation on regulatory standards and compliance regarding validation activities
  • Participates in internal and external Regulatory audits and external vendor audits
  • Provides support for other CSV-related initiatives and validation/quality improvement projects
  • Additionally, may assist with corporate validation initiatives and assist with the documentation of validation efforts to meet FDA compliance requirements, when applicable

Education and Experience

  • Working knowledge of FDA/GxP; Strong working knowledge of Pharmaceutical (21 CFR 11, Annex 11 and/or 820)
  • Regulations and software technical aptitude
  • Ability to prepare, execute, and analyze validation studies and validation protocols
  • Ability to communicate project status, issues, risks, plans, etc. within the organization
  • Demonstrated experience working in a regulated environment requiring adherence to government or regulatory body policies and procedures
  • Demonstrated knowledge of Quality Management Systems tools
  • Should be able to lead software validation projects and change control efforts
  • Able to respond/react with appropriate urgency/professionalism and make decisions under pressure
  • Supports goals and initiatives tied to the Quality Plan and departmental goals
  • Ability to interface effectively with cross-functional teams resulting in overall regulatory compliance
  • Ability to communicate effectively both orally and in writing
  • Good analytical, problem-solving and conceptual skills
  • Strong attention to detail
  • Ability to resolve system validation issues effectively and efficiently

TrialScope is an Equal Opportunity Employer