QA Computer Systems Validation Specialist

Labcorp•South San Francisco, CA

1d•$115,000 - $135,000•Onsite

About The Position

Labcorp is seeking a Computer Systems Validation (CSV) Specialist to join the Monogram Biosciences laboratory in South San Francisco. This fully onsite role supports quality assurance activities related to computer systems, software, and laboratory equipment. The specialist works with IT, users, business process owners, consultants, Quality, and other stakeholders to manage change control and validation activities, ensure appropriate documentation and testing, and provide compliance guidance. Monogram Biosciences develops and commercializes diagnostic products and supports pharmaceutical companies developing therapeutics and vaccines. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m., at 345 Oyster Point Boulevard, South San Francisco, California. The stated pay range is $115,000 to $135,000 per year.

Requirements

Bachelor’s degree in Information Technology, Computer Science, Biological Science, or Clinical Laboratory Science.
At least 2 years of experience performing computer validations in Quality Assurance.
At least 1 year of experience in a regulated environment, such as Part 820 QSR, ISO 13485, GxP, CAP, or CLIA.
Ability to interact effectively with Research, Process Development, Support Operations, Customer Service, MCRL, IT, and Clinical Research departments.
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.

Nice To Haves

Current or prior Labcorp experience.

Responsibilities

Manage and maintain the IT Change Control System.
Manage validation activities effectively across IT, user and business process owners, consultants, and Quality.
Design and prepare test plans and test cases in collaboration with IT and user groups, including key stakeholders and subject-matter experts.
Execute protocols, report exceptions, and participate in exception analysis and resolution.
Participate in the review and approval of data specifications and formats for pharmaceutical sponsors and similar clients.
Participate in assembling and reviewing IT change-control indicators and metrics.
Assess computer-based laboratory instruments to determine software validation requirements.
Participate in software project teams, define validation requirements, and provide compliance guidance for validation activities when appropriate.
Perform equipment qualification (IQ, OQ, PQ) on laboratory equipment and instruments.
Maintain other Quality functions as designated by QA management.