Quality Specialist, Quality Assurance

About NJOY: 

NJOY is one of the largest independent electronic nicotine device (ENDS) companies in the U.S. and a leader in the revolution against combustible cigarettes. With a mission to Make Smoking History, adult smokers have trusted the NJOY brand to offer a range of satisfying electronic nicotine products as an alternative to combustible cigarettes since 2007. In April and June 2022, NJOY made history when the US Food and Drug Administration issued Marketing Granted Orders for NJOY’s ACE Device and Pods and NJOY’s Daily Disposable E-Cigarette, reflecting FDA’s determination that these products are “appropriate for the protection of public health”. With that decision, NJOY became the only company independent of Big Tobacco to receive Marketing Granted Orders for their ENDS products. Exemplary of its commitment to contributing to the improvement of public health, NJOY developed the Standard Research Electronic Cigarette in exclusive partnership with the National Institute of Drug Abuse (NIDA) for use in independent, government-funded clinical studies. 

At NJOY, we are adamant that our mission is at the center of everything we do – this includes hiring the right team members to continue to build this History-making company. If you want to make history while being surrounded by the best and brightest colleagues, read on to learn more about this opportunity.

Overview: 

The Quality Specialist, Quality Assurance will ensure that the quality standards of the company are maintained within procedures, policies, purchased components and manufactured products. The Quality Specialist, QA will support the implementation of processes and procedures including the eQMS as well as support other functions of the Quality Department as needed.

Primary Responsibilities: 

• Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
• Document control, creation of quality documents, and review/approval of controlled documents
• Change management and review of change controls
• Training program; conduct training when needed
• Execution and continual improvement of QMS program

• Member of the internal auditing team, participate in conducting internal audits
• Assist Quality Control & production departments in the evaluation of quality issues (including customer & supplier issues) using statistical & problem-solving techniques to determine root cause, implement corrective & preventive actions and improve processes
• Assist in resolution of quality issues by communicating effectively with internal and external customers
• Support the upkeep of the Quality Document Management System, including but not limited to: Batch Records (master records and executed records), Change Controls, Deviations/Investigations, Audit Reports, Corrective Action Requests, Standard Operating Procedures, Annual Product Reviews, and Customer Complaints.
• Participate in Quality and Compliance Vendor Management activities including audits and site-visits as needed.

Minimum Qualifications: 

• Strong computer skills, i.e. Excel/Word/Adobe/PowerPoint/SmartSheets/Visio/eQMS
• Requires a bachelor’s degree preferably in a life science, engineering or business-related field plus a desired 2-5 years of relevant experience. 
• Requires the ability to read, write, and communicate fluently in English.
• Experience working in a highly regulated industry.

Preferred Qualifications:

• Strong knowledge of cGMP requirements and relevant industry standard practices is required. Demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems.
• Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment.
• Experience with international regulatory requirements and international business partners is preferred.
• Experience working on complex projects with remote team members.
• Experience with statistical software programs.
• Ability to work with a wide range of people for process improvements and corrective actions.
• Ability to work independently and within team environments.
• Ability to conduct internal audits with minimal supervision.
• Experience with QMS software applications.

Why Work for NJOY?

• You'll be working in a high energy, fast-paced environment with a best-in-class team, collaboratively driving toward our mission to Make Smoking History
• An unparalleled opportunity to make an impact
• A comprehensive and personalized orientation and 6-month onboarding program
• Monthly cell phone reimbursement
• Commuter benefits for transit 
• Competitive employee benefits including medical, dental, vision, and monthly wellness offerings
• 401k with robust employer-match 

EEOC Statement:

NJOY is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. NJOY is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex (including pregnancy), national origin, age, disability, marital status, sexual orientation, genetic information, uniform service member, or veteran status, or any other characteristic protected by federal, state or local law. Further, NJOY complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. NJOY is an e-verify employer. 

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