Computer System Validation Specialist, Quality Assurance

THE COMPANY:

JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.

 We’re an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.

ROLE AND RESPONSIBILITIES:

JUUL Labs is searching for a Computer System Validation Specialist, Quality Assurance to join our team. In this role, Computer Systems Validation (CSV) Specialist will provide computer systems validation oversight and execution across the IT System Development Lifecycle for all applications that support JUUL Labs  GxP regulated activities, and ensure compliance with Code of Federal Regulations (CFR) 21 Part 11 regarding electronic records and electronic signatures.

  • Liaises with IT and other cross-functional business teams in the development of GxP deliverables, SOPs, Work Instructions, Policies and other critical documentation for GxP regulated computerized systems
  • Ensure GxP computer systems are designed, validated and operated in compliance with applicable regulatory requirements and JUUL’s internal procedures.
  • Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5.
  • Applies knowledge of Cloud-based, SaaS systems, thoroughly interprets CSV regulations, guidelines and GxP practices and meets regulatory compliance.
  • Responsible for authoring, reviewing and approving validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, testing Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
  • Experience with systems including (but not limited to) on-premise and cloud solutions such as SAP H4/HANA, Veeva, LIMS, Serialization solutions; as well as networks/infrastructure and hardware qualification.
  • Communicate Computer System Validation approaches and requirements during audits.
  • Review and approve change controls related to GxP computerized systems.
  • Define, implement and lead vendor audits and internal audit/periodic reviews related to computer systems.
  • Provide training on validation related topics.
  • Mentor and provide direction to direct and indirect reports (as needed) and manage team resources.

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

  • Experience in GxP regulated industry
  • A minimum of 8 years in direct hands-on experience validating GxP Computerized Systems
  • Advanced knowledge of GxP regulations and approaches to System Life Cycles (SLC) and GAMP
  • Excellent written and oral communication skills.
  • Strong planning, organizing, and execution skills.
  • Ability to proactively manage workload and meet deadlines.
  • Develop and implement creative solutions to improve processes.

EDUCATION:  

  • Bachelor’s degree in life sciences, computer sciences, or a related field

JUUL LABS PERKS & BENEFITS:

  • A place to grow your career. We’ll help you set big goals - and exceed them
  • People. Work with talented, committed and supportive teammates
  • Equity and performance bonuses. Every employee is a stakeholder in our success
  • Boundless snacks and drinks
  • Cell phone subsidy, commuter benefits and discounts on JUUL products
  • Excellent medical, dental and vision benefits
  • Location. Work in the heart of San Francisco, one of the world’s greatest cities

JUUL Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. JUUL Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for JUUL Labs in the US.

JUUL LABS PERKS & BENEFITS:

  • A place to grow your career. We’ll help you set big goals - and exceed them
  • People. Work with talented, committed and supportive teammates
  • Equity and performance bonuses. Every employee is a stakeholder in our success
  • Boundless snacks and drinks
  • Cell phone subsidy, commuter benefits and discounts on JUUL products
  • Excellent medical, dental and vision benefits

JUUL Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. JUUL Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have the authorization to work for JUUL Labs in the US.

Vapor, JUUL, Work Culture, Fast Paced, Start-up, Growth, Vape, Technology, Software, Hardware, Consumer Electronics, Manufacturing, Design, Product, Disruptive, Revolutionary, Cutting Edge, App, Android, eCommerce, B2C, San Francisco, Bay Area, IoT, San Jose, Los Angeles

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