Computer System Validation Specialist will work the Natera Software Engineering team to ensure appropriate software documentation is in place to support changes to Laboratory and Product software systems. Working with the QA Software Manager this position will provide value-added guidance throughout the software development lifecycle process.
PRIMARY RESPONSIBILITIES
Participate in software risk management activities
• Perform risk and/or impact assessments for Lab, Product, and Quality Management software systems
• Review software change requests and maintenance updates along with associated test plans, protocols, and reports
Participate and/or lead computer system validation projects
• Draft IQ/OQ/PQ software plans, protocols, and reports
• Ensure validation state of software systems are maintained
• Act as subject matter expert for CSV compliance during internal and external audits
• Perform audit trail reviews
Participate and/or lead cross-functional teams to investigate and resolve software nonconformities, deviations, CAPAs, and complaints.
May support quality system audits as subject matter expert in computer system validation.
Responsibilities are assigned based on demonstrate competency.
QUALIFICATIONS
• BS Degree or equivalent work experience
• 3-5 years’ experience within a dedicated CSV or product software validation role
• Experienced working in a CLIA Laboratory environment and/or FDA regulated environment
KNOWLEDGE, SKILLS, AND ABILITIES
• Preferred experience/knowledge with Microsoft Great Plains, Confluence, JIRA, SuccessFactors, LIMS, EDMS
• Extensive knowledge of QA methodologies, test planning, system dependencies, and product integration phases.
• CSV III: Extensive knowledge of regulatory requirements for software design and change control (lifecycle management
• Knowledge of regulatory requirements for non-product and product software (IEC 62304, 21 CFR Part 11, 21 CFR Part 820.30 and 820.70(i), CLIA, etc.)
• Strong knowledge of QA methodologies (such as root cause analysis), test planning, system dependencies, and product integration phases.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear.
• The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.
• Limited travel required
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information: - BBB announcement on job scams - FBI Cyber Crime resource page