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QA Computer Systems Validation (CSV) Specialist

Company: Labcorp
Location: South San Francisco
Posted on: June 7, 2021

Job Description:

Monogram, part of LabCorp, is seeking a Computer Systems Validation Specialist to join its team in South San Francisco! This position is primarily responsible for executing Monogram Biosciences' IT Change Control System. The QA Computer Systems Validation Specialist will work closely with the QA Validation group, IT/Software Development Team, and User Groups to design test plans and prepare test cases for validation of systems, applications, hardware components and customized applications for certain lab based instruments. This position is also responsible for test execution, exception reporting, assisting in exception analysis and resolution. The majority of the computer systems that this position will be working on are in-house developed programs for laboratory equipment.

Please note, this position will be working onsite. Some remote work is possible on occasion based on projects, but this is NOT a 100% remote role.

Additional Responsibilities Include:

  • Participation in software project teams, defining validation requirements and when appropriate, provide compliance guidance for validation activities
  • Closely working with QA management and other members of Quality, IT/Automation and User Groups, the CSV will support a standardized approach to all validation policies and procedures, templates and documentation
  • Management of technical validation activities between cross-functional groups such as IT development, user and business process owners, consultants and Quality.
  • Performing Equipment Qualification activities (IQ, OQ, PQ)

About Monogram:

Monogram Biosciences, Inc.(a wholly-owned subsidiary of LabCorp), is a leader in developing and commercializing innovative diagnostic products to help guide and improve the treatment of HIV, HCV, and other viral illnesses, as well as cancer and other diseases. Monogram's services enable health care providers to optimize treatment regimens for their patients. Monogram also supports pharmaceutical companies in developing new and improved antiviral therapeutics and vaccines and targeted cancer therapeutics. Located in South San Francisco, Monogram provides an innovative and flexible work environment, where you will have the opportunity to be part of pioneering new diagnostics technologies.

Keywords: Labcorp, South San Francisco , QA Computer Systems Validation (CSV) Specialist, Other , South San Francisco, California

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