QA Computer Systems Validation Specialist

Labcorp; South San Francisco (CA); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

401(k)

PTO/FTO

Tuition Reimbursement

Employee Stock Purchase Plan

Job summary

Labcorp is seeking a Computer Systems Validation (CSV) Specialist to join our Monogram Biosciences lab in South San Francisco. This on-site role supports IT Change Control, validation activities, and equipment qualification within a regulated biolab environment.

The ideal candidate has a degree in IT/CS/biological or clinical lab science and 2+ years in computer validations, plus 1+ year in regulated settings. Monogram provides a collaborative, mission-driven team in South San Francisco.

Qualifications

• Bachelor’s 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.

Responsibilities

• Manage and maintain the IT Change Control System.
• Coordinate validation activities between IT, user and business process owners, consultants and Quality.
• Design and prepare test plans and test cases with IT and users and SMEs.
• Execute protocols, report exceptions and participate in exception analysis and resolution.
• Contribute to data specifications and approval process for Pharma sponsors and clients.
• Assist in IT change control indicators and metrics.
• Assess computer-based laboratory instruments to determine software validation requirements.
• Participate in validation guidance for software project teams as needed.
• Perform Equipment Qualification (IQ, OQ, PQ) on laboratory equipment and instruments.
• Support other QA functions as directed.

Education

Bachelor’s degree in Information Technology, Computer Science, Biological or Clinical Laboratory Science

Job description

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

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

Work Schedule

Monday – Friday, 8:00am – 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’s 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

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

All job offers will bebased on a candidate’s skills and prior relevant 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
• Employee Stock Purchase Plan
• Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in 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, please.

Labcorp Is Proud To Be An Equal Opportunity Employer

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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