Quality Data Analyst

NJOY - Baraboo, WI4.7

Full-time

About NJOY:

NJOY is one of the largest independent vaping companies in the U.S. and a leader in the revolution against cigarettes. With a clear mission to Make Smoking History, NJOY offers a range of e-cigarettes and vaping devices for the millions of adult smokers looking for an alternative. NJOY is driven in its mission and commitment to improve the lives of adult smokers.

Overview:

The Quality Data Analyst will ensure that the quality standards of the company are maintained within NJOY’s procedures, policies, purchased components and manufactured products. The Quality Data Analyst will support complaint and CAPA investigations as well as support other functions of the QMS as needed.

This position is responsible for monitoring the data output of the processes and product quality of NJOY products, performing trend analysis, and initiating problem solving, corrective action and containment for identified deficiencies. This includes completion of all supporting documentation.

Responsibilities:

  • Build out Statistical Process Control Charts (SPC) for all data points being received from contract manufacturers
  • Compile graphs and charts that clearly depict the capability of all manufacturing processes
  • Maintain a dashboard of metrics on supplier performance against targets
  • Support product release and change activities in support of new and existing products.
  • Build out modules within NJOY’s eQMS solution to house and track all Quality data
  • Coordinate, review and manage document/procedure change work flow. Review other documentation for accuracy.
  • Update, review and manage SOP documentation work flow.
  • Assist in the administration of the Product Complaint and CAPA systems
  • Review of required batch release testing and test data
  • Supplier documentation management
  • Assist in the preparation of NCRs and return to vendors
  • Assist in preparing Quarantine Release documents
  • Oversight over product acceptance of Incoming materials and in process materials
  • Assist in the upkeep of the Quality and Compliance Document Management System at NJOY. Documents to be maintained include but are 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.

Skills:

  • Knowledge of cGMP requirements and relevant industry standard practices is preferred with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems.
  • Knowledge of quality systems and product/process lifecycle management within a manufacturing environment.
  • Strong knowledge of statistical techniques and software (Minitab or similar)
  • Expert computer skills required including Microsoft Word, Excel, Visio, PPT, and Project
  • Excellent communications skills both written and oral, including ability to navigate potentially challenging situations both internal and external to the business during the coordination of QMS programs.
  • Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively in order to expedite the successful execution of assigned work.
  • Efficient organizational skills, including the ability to manage multiple processes and priorities effectively.

Experience/Background:

  • Requires a bachelor’s degree in a life science, engineering, math, or business-related field plus a desired 3-5 years of relevant experience. Experience includes Statistician, Business Analyst or Quality Assurance/Control in a regulated environment.
  • Experience with international regulatory requirements and international business partners is preferred.

Job Type: Full-time

Education:

  • Bachelor's (Required)

Work Location:

  • One location

Benefits offered:

  • Paid time off
  • Health insurance
  • Dental insurance
  • Healthcare spending or reimbursement accounts such as HSAs or FSAs
  • Other types of insurance
  • Retirement benefits or accounts
  • Others