Lab Quality Associate

Juul Labs • Mountain View, CA

5d • Onsite

About The Position

Juul Labs mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent. We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career is compelling, read on for more details. ROLE AND RESPONSIBILITIES: The Laboratory Quality Associate reports to Lab Quality Senior Manager and performs the routine quality assurance activities to ensure the highest levels of technical and process excellence. This role will be on site in our Mountain View, CA laboratory. The Laboratory Quality Associate is responsible for ensuring compliance with FDA 21 CFR Part 58 (Good Laboratory Practices for Nonclinical Laboratory Studies), as well as JUUL Labs Global Quality QMS and regulatory requirements. Performs GLP study based in-phase, protocol, and report audits. Performs reviews of project data to ensure compliance with test methods, protocols, and SOPs. Issues QA statements for inclusion in final reports. Maintain records in accordance with GLP archival requirements Provide QA support for Research and Development (R&D) laboratory teams. Support R&D Lab Quality Implementation goals for equipment management, documentation, training needs and other areas as assigned by the Lab Quality Senior Manager. Perform scheduled reviews of laboratory notebooks and logbooks, temperature logs, laboratory equipment and reagents, etc. and clearly and accurately record results and relay to laboratory staff. Ensure deviations and NCRs are documented and appropriately addressed. Assist laboratories with NCR and CAPAs. Write and review SOPs and Wis. Provide external audit support. Foster effective relationships to enhance department objects. Collaborate cross-functionally across each Quality Department to support quality team goals, solve problems and improve quality. Other quality assurance duties as assigned by the Lab Quality Senior Manager.

Requirements

• Minimum 2-3 years of laboratory quality assurance experience in a GLP-regulated laboratory environment is preferred.
• Working knowledge of FDA 21 CFR Part 58
• Experience auditing raw data and final data reports is preferred.
• Ability to understand and implement processes from SOPs and work instructions.
• Ability to review laboratory documentation against SOP requirements.
• Ability to understand FDA guidelines and regulations.
• Good proofreading, documenting, and editing skills (Microsoft Word/Excel/Adobe PDF Skills)
• Excellent attention to detail, sound judgment, and ability to work independently.
• Ability to prioritize tasks and deliver assignments with high quality in a timely manner.
• Able and willing to wear protective equipment such as gloves, lab coats and safety glasses while performing duties in the laboratory, as well as adhere to laboratory dress code (no shorts, no open toed shoes, etc).
• Bachelor’s Degree or equivalent combination of education/experience in science, life sciences, pharmaceutical, or health related field required.

Nice To Haves

• ISO 17025 experience a plus.

Responsibilities

• Performs GLP study based in-phase, protocol, and report audits.
• Performs reviews of project data to ensure compliance with test methods, protocols, and SOPs.
• Issues QA statements for inclusion in final reports.
• Maintain records in accordance with GLP archival requirements
• Provide QA support for Research and Development (R&D) laboratory teams.
• Support R&D Lab Quality Implementation goals for equipment management, documentation, training needs and other areas as assigned by the Lab Quality Senior Manager.
• Perform scheduled reviews of laboratory notebooks and logbooks, temperature logs, laboratory equipment and reagents, etc. and clearly and accurately record results and relay to laboratory staff.
• Ensure deviations and NCRs are documented and appropriately addressed.
• Assist laboratories with NCR and CAPAs.
• Write and review SOPs and Wis.
• Provide external audit support.
• Foster effective relationships to enhance department objects.
• Collaborate cross-functionally across each Quality Department to support quality team goals, solve problems and improve quality.
• Other quality assurance duties as assigned by the Lab Quality Senior Manager.

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
• Cell phone subsidy, commuter benefits and discounts on JUUL products
• Excellent medical, dental and vision, disability, and life insurance, plus family support, wellness, legal, and employee assistance program benefits
• 401(k) plan with company matching
• Plus biannual discretionary performance bonuses

What This Job Offers

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