THE COMPANY:

Juul Labs’ mission is to impact the lives of the world’s one billion adult smokers by eliminating combustible cigarettes. 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 at one of the fastest growing companies is compelling, read on for more details.

ROLE AND RESPONSIBILITIES:

As a part of the Quality Systems team, the Document Control Training Specialist will work under the direction of the Sr. Manager, Change Control and Training to support new on-going document control and training initiatives as well as support day-to-day activities. Activities will include, but are not limited to, support of document control/training process and system improvements, document review and formatting, working in the eLearning Management System, and troubleshooting with eDMS and LMS users. The Document Control Training Specialist will participate in independent and team projects as defined by the Manager.

KEY RESPONSIBILITIES:

• Collaborate with cross-functional departments to ensure timely implementation of document change requests and associated change control associated tasks as required
• Facilitate the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator
• Review, edit, and format master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, and prepares distributions and archiving
• Assist with issuance of documents, including logbooks and labels, and maintains issuance logs
• Assist with, and provides, on-going user support for electronic document management systems
• Working with department heads, administrate departmental training curriculum updates in the Learning Management System (LMS) based on changing needs of departmental training plans and as training documents become effective, updated, or retired
• Ensure quality driven learning needs are deployed in the LMS; including procedural training, online courses, instructor led courses, working with Quality Business and LMS Stakeholders as required
• Assist with management and administration of Veeva Quality Management Systems (QMS) and Quality Docs
• May also support the preparation of internal audits and regulatory (e.g. FDA, EMA, DHHS, etc.) inspections
• Drive continuous improvement

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

• A minimum of 3 years relevant work experience is required. It is preferable that the candidate has experience working in a cGMP manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy
• GxP Quality System knowledge, including relevant regulations and guidances (e.g. ISO 13485, ICH Q10, Part 11/Annex 11)
• Operational experience with electronic quality systems
• Experience with Document Management Systems (i.e.Veeva/ Documentum) is preferred
• Experience with Learning Management Systems (ex. ComplianceWire, Cornerstone, Veeva) is preferred
• Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills
• Flexible, highly motivated, with strong organization skills, ability to multi-task with attention to detail
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment
• Effective interpersonal skills with the ability to collaborate / communicate within all disciplines of the organization
• Ability to work independently with a high degree of accountability
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and Google applications (sheets, docs, forms)

EDUCATION:

• A minimum of a bachelor’s degree or equivalent experience in Science, Information Science or similar technical discipline is required

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
• 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 authorization to work for Juul Labs in the US. #LI-remote