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Computer System Validation Specialist IV

Natera

Natera

San Carlos, CA, USA
Posted on Tuesday, June 4, 2024

POSITION SUMMARY:

The CSV Specialist IV comes with leadership skills and managerial capabilities to support the quality system & processes of the Natera's medical device, lab, clinical and quality software. The CSV IV works with multiple functions to conduct computerized system validation activities. This position represents compliance requirements (including 21 CFR part 11, part 820 & annex 11 compliance) related to software implementation, leads audits (internal, supplier, and external), leads CSV activities following CSV procedure.

With limited supervision works with Natera Software Engineering and cross-functional teams to ensure appropriate software documentation is in place to support computer system validation. Working with QA leadership, this position will provide value-added guidance throughout the software lifecycle. 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. Support internal and external audits (Part 11, 820, CLIA/CAP, ISO 13485). Support CAPA, Deviation, and Nonconformance investigation and reporting. Other duties as assigned.

RESPONSIBILITIES:

  • Lead computerized system validation (CSV) activities for Lab, Product, and Quality Management software systems.
  • Review software change requests and maintenance updates following change control and maintenance release process.
  • Author s/w validation & test plan, protocols, report, develop software trace matrices and provide guidance on drafting requirements, specifications and procedures; perform risk based validation testing, and ensure validation state of software systems are maintained.
  • Review & provide guidance on Spreadsheet validation projects.
  • Support preparation and execution of s/w internal audits, s/w supplier audits as well as hosting external audits related to software.
  • Participate and/or lead cross-functional teams to investigate and resolve software nonconformities, deviations, CAPAs, and complaints.
  • Partners with leadership to implement strategies for software compliance.
  • Participate in development of regulatory content for submissions to regulatory authorities.


QUALIFICATIONS

  • 10+ years of work experience in Biotech industry preferred or a relevant combination of skills, education and experience
  • Bachelor’s degree in life sciences, engineering, software or equivalent
  • ASQ or SQA certification preferred

KNOWLEDGE, SKILLS & ABILITIES:

  • Ability to grow as a people manager, leading large, complex software validation projects, including custom software application validation.
  • Knowledge of CSV procedure, GAMP 5 V model, regulatory requirements for non-product and product software (21 CFR Part 11, part 820, Annex 11, 13485, IEC 62304, 14971) to be able to respond to SQA/CSV related regulatory/compliance queries.
  • Extensive knowledge of QA methodologies, test planning, system dependencies, and software SDLC phases.
  • Good at task execution, working in agile environment, ability to work independently as well as in a team, with good communication skills.
  • Preferred experience with validation of lab, clinical & quality s/w systems (e.g. LIMS, eTMF, CTMS, EDMS, etc)
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
San Carlos, CA
$1$1 USD

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