QA Computer Systems Validation Specialist

Labcorp is seeking aComputer Systems Validation (CSV) Specialist to join our Monogram Biosciences lab in South San Francisco!

Work Schedule: Monday 6 Friday, 8:00am 6 5:00pm

Address: 345 Oyster Point Boulevard, South San Francisco, CA. Note: this is a 100% onsite position

Job Responsibilities

• Management and maintenance of the IT Change Control System
• Effective management of validation activities between cross-functional groups such as IT,
• user and business process owners, consultants and Quality
• Design and preparation of test plans and test cases in collaboration with IT and user
• groups including key stakeholders and SMEs
• Protocol execution, exception reporting, participating in exception analysis and resolution
• Participation in the data specifications and format review/approval process for Pharma
• sponsors and similar clients
• Participating in the IT change control indicators and metrics assembly and review
• Assessment of computer-based laboratory instruments to determine software validation
• requirements
• Participation in software project teams, defining validation requirements and when
• appropriate, provide compliance guidance for validation activities
• Performing Equipment Qualification (IQ, OQ, PQ) on laboratory equipment and instrument
• Maintenance of other Quality functions as designated by QA management

Minimum Qualifications:

• Bachelor 27s degree in Information Technology, Computer Science, Biological or Clinical Laboratory Science
• 2 years or more experience with performing computer validations in QA
• 1 year or more experience in a regulated environment, such as Part 820 QSR, ISO 13485, GxP or CAP or CLIA

Preferred Qualifications:

• Current or prior Labcorp experience

Additional Job Standards:

• 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

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.

**Pay Range: $115,000 - $135,000 / year

All job offers will bebased on a candidate 27s skills andpriorrelevant experience, applicabledegrees/certifications,as well as internal equity and market data.

Benefits:Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.Employees regularly scheduled to work less than 20hours,Casual, Intern, and Temporary employees are only eligible toparticipatein the 401(k) Plan.Employees who are regularly scheduled toworka 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information, pleaseclick here.