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 ENVIRONMENTThe 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
WHAT WE OFFERCompetitive 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.
