Computerized Systems Validation Specialist II

Sarah Cannon Research Institute

1d • Remote

About The Position

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. Our Computerized Validation Specialist II provides subject matter expertise on computer system validation and policies at Sarah Cannon Research Institute (SCRI) and Genospace. Additionally, the Computerized Validation Specialist II supports the validation strategy and policies at Sarah Cannon Research Institute (SCRI) and Genospace. This is a remote position based in the US; relocation assistance and visa sponsorship are not available.

Requirements

• Bachelor's Degree highly preferred; work experience may be substituted for education
• 3-5+ years' work experience in a clinical research, life sciences, or CRO focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
• Experience should include industry and international standards for software quality such as GAMP V, PIC/S, ICH, etc.
• Experience should include pharmaceutical, biologics, CRO, and/or medical device industry 21 CFR Part 11 requirements and software validation principals.
• Exceptional time management and organizational skills, and experience working as part of a cross-disciplinary team and relating to a diverse number of coworkers.

Nice To Haves

• Knowledge of EU regulations, e.g., Annex 11 is helpful.

Responsibilities

• Works with internal and external customers to ensure compliance with applicable regulations.
• Helps other Validation Specialists and technical team members to ensure successful delivery of the validated system to meet SCRI business need.
• Authors computer system validation documentation ensuring compliance with applicable regulations.
• Participates on project teams (i.e., business, research applications, developers, IT Infrastructure and Security) throughout the software installation, configuration, testing, and implementation process.
• Works with development team in translating functional requirements into clearly specified product features.
• Ensures continued regulatory compliance during software implementation projects and structured development life cycle practices and methodologies.
• Authors validation deliverables including but not limited to risk/impact assessments, validation plans, requirements traceability, and validation summary reports.
• Other duties as assigned

Benefits

• We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being.
• Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.
• As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level