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Quality Control Process Technical Analyst

Facility:  Quality
Location: 

Clayton, NC, US

About the Department   

At Novo Nordisk, we want to make a difference. For nearly 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. 
 
In Clayton, NC, we now operate two adjacent pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  
 
Our Clayton, NC Diabetes Finished Products (DFP) facility is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. When you work at DFP, you’ll join a global network of manufacturing professionals focused on several key, final production processes, including sterile formulation, filling, inspection, device assembly and packaging. 
 
At DFP, our employees are passionate about what they do, knowing their work makes a difference to millions of people who rely on our products every day. After all, producing medicines is a special responsibility. 
 
Join Team Novo Nordisk and help us make what matters.

This role is in QC Support and requires sample coordination responsibilities

 

Position Purpose

Provides support to Quality Control (QC) Department by driving continuous improvement, optimization and innovation as well as leading systematic problem solving & change requests. Works with members of the departmental leadership team to share best practices with internal/external departments & sites. Will be responsible for one or more of the below accountabilities.

 

Accountabilities

  • DAPI US & Site Clayton Global LIMS Site SuperUser and QC Static Builder responsible for training and building of QC methods
  • Statistical Process Control (SPC) system owner for Site Clayton responsible for roll out of the system. Responsible for driving continuous improvement, innovation and optimization projects in QC
  • Responsible for driving large scale investigation, change requests, and inspection/audit findings
  • Lead & coach departmental personnel, specialists, leaders, & process technical analysts in problem solving for process & quality issues
  • Understands the processes of data evaluation and trending
  • Closely interacts with all areas to improve the flow of information & data
  • Expert level of knowledge & understanding regarding departmental processes & their high-level inter-relationships (i.e. how they work together to establish a system)
  • Other accountabilities, as assigned

 

Required Qualifications

  • BS/BA in technical field or industry equivalent experience
  • Minimum of five (5) years of QC experience in a pharmaceutical or related (regulated) environment
  • Demonstrated expert understanding of processes, procedures & products associated with assigned areas
  • Able to perform detailed analysis of events & processes, develop appropriate responses to situational needs, & convey information/results to various organizational levels as appropriate
  • Excellent verbal & written communication skills, investigative writing skills, & computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP & LIMS)
  • Demonstrated experience in practical problem solving & process improvement methods
  • Demonstrated ability to manage multiple tasks/deadlines & prioritize properly based on process needs & events
  • Demonstrated effectiveness in systematic follow-up

 

Desired Qualifications

  • Leadership/Supervisory experience preferred
  • Demonstrates knowledge of adult learning methodologies & is able to use multiple methods to train & coach others within the department & organization

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility using various body positions
  • Able to do close precision work with hands
  • Able to remain in a stationary position 50% of the time
  • Corrected vision to 20/30 & ability to see all colors
  • Occasionally ascends/descends a ladder to take samples
  • Occasionally works around odorous and/or hazardous materials
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation

 

Millions rely on us 
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.