Laboratory Corporation of America QA Computer Systems Validation (CSV) Specialist - Mongoram Biosciences in South San Francisco, California
Monogram, part of LabCorp's Specialty Testing Group, 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.
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)
BS/BA in Information Technology/Computer Science, Biological or Clinical Laboratory or other related discipline
2-5 years of experience with performing computer validations
Previous experience working in a regulated environment and working in biotech/pharma, clinical laboratory or similar industries highly desired
Previous experience working in an FDA regulated, GMP, and/or CLIA/CAP environment a huge plus
Ability to interact effectively with various departments: Research, Process Development, Support Operations, Customer Service, MCRL, IT, and Clinical Research.
Excellent (written and verbal) communication and interpersonal skills, solid organizational skills, and ability to contribute to a collaborative, flexible work environment
Strong documentation skills
Technical understanding of clinical laboratory operations is a plus
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.
Monday - Friday, 8:00am-5:00pm
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.