Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

QA Software Validation Analyst

Job Code: #799
Job Type: Contract
Salary: $70.00 - $80.00/hour
Job Location: Lincolnshire, IL
Posted 2 months ago

Job Description

Job Title:  QA Software Validation Analyst

Pay:  $70.00 - $80.00 per hour

Job Overview:  The Analyst, Quality Assurance, Software Validation, will be required to provide direction and hands on technical assistance on a variety of system validation projects while also continuing to identify areas for improvement within the Quality System.  Exercise the Product Design and Development Process as it relates to Design Control, Computer Systems Validation, Quality Systems, and Technology in general. Scope of business applications to be potentially supported will range across GMP, GCP, and GLP regulatory areas.

  • Responsible for guiding validation and developing/reviewing validation deliverables (i.e., Validation Plans, Software Requirement Specifications, Software Design Specifications, Risk Analysis, Test Plan & Protocols, Validation Summaries and Reports) based on the Product Design and Development process.

  • Responsible for ensuring new development and maintenance of applications are in compliance with procedures related to validation, validation master plans, software lifecycle management, software product design control, and change control including risk management.

  • Responsible for working collaboratively with Regulatory Affairs, Quality Assurance, Corporate and Enterprise Systems, Technical Service and others to support and improve Product Development, Design, Validation and Change Control processes.

  • Assists RA/QA organizations with software-related new releases, customer complaints, CAPA and Field Correction / Recall activities, Engineering Change Requests and documents used by the Technical Services team and distributed to customers.

  • Responsible for review/approval, compliance and oversight of Design and Validation-related activities associated with, but not limited to, infrastructure and processes, SAI IVD and Health IT products and Corporate Support Systems such as CRM, SAP and other internal ”home grown” (i.e., Insight, GEA-RMS) systems used to support the sales, service, and supply chain activities of the Americas business.

  • Support of Company's Design and Validation activities including, but not limited to, new and changing manufacturing equipment and processes.

  • Act as a resource for validation and software lifecycle management for global Company partners.

  • Support completion of assigned project activities as required.

  • Additional requirements as assigned.

Requirements:

  • Bachelor’s degree or 3-5 years required experience in software systems and software validation processes, Quality Assurance including experience in the Armed Forces.

  • Knowledge and experience in the following areas:

    • Medical Device quality systems including design control and Software development processes. Understanding of risk management and its application in design and quality systems.

    • Medical device CAPA evaluation, rework, and resolution

    • FDA QSR and Part 11; and ISO 13485, 14971

    • Computer software design and software life cycle management.

    • Principles and practices of qualification, verification and validation.

    • IT products and Corporate Support Systems such as CRM, SAP

  • English proficiency

  • Personal computer operations and Microsoft applications (Word, PowerPoint, and Excel)

  • Skill in responding to common inquiries or complaints from internal customers, regulatory agencies and members of Company management.

  • Analyzing problems, identifying alternative solutions, projecting consequences of proposed actions and implementing recommendations in support of project completion and goals

  • Interpreting software logic diagrams and flowcharts.

  • Ensuring compliance with all Company policies and procedures.

  • Training and coaching others.

  • Communicating clearly and concisely, both orally and in writing.