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Process Area Specialist I - AP

About the Department

At Novo Nordisk, we want to make a difference. For more than 95 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. Help us bring quality to life. Our filling and finishing facility (DFP) is a 457,000 square foot aseptic "fill and finish" manufacturing facility located in Clayton, NC and employs more than 850 people. The facility is part of a global network of manufacturing sites responsible for several key steps in the diabetes treatment manufacturing process, including sterile formulation, filling, inspection, device assembly and packaging. Producing medicines is a special responsibility. Our employees are passionate about what they do, knowing that their work makes a difference to millions of people who rely on our products every day. Are you ready to make a difference?

 

Purpose

Process Area Specialist I will be required to do environmental excursion & aseptic process deviations. They perform investigations to determine the root cause analysis & the required corrective actions. They also perform effectiveness checks from the deviations to ensure the corrective actions were successful. They will also perform systematic problem solving to put in place corrective actions higher on the hierarchy of control. They perform coaching & training for those involved in deviations.

 

Accountabilities

Aseptic (AP)

  • Responsible for investigation & solution of Aseptic Production quality problems
  • Deviations Minor & Major; Customer Complaints
  • Ensure compliance with training programs (ISOtrain/Eduneering)
  • Work directly with shift teams and/or APTS to provide quick containments & in-depth root cause analysis
  • Work directly with QAAP to provide better written deviations & investigations
  • Drive effectiveness of quality processes. Reduce number of major deviations & improve the timeliness of investigations
  • Actively communicate corrective actions from investigations & confirm with all shift teams
  • Ensure compliance with DFP standards
  • Work with Process Technical Analysts & QA to develop simplicity in the deviation process
  • Responsible for developing & performing training on aseptic concepts
  • Responsible for identifying aseptic process needs & improvement opportunities
  • Responsible for performing root cause analysis investigations for aseptic process deviations through use of SPS tools
  • Responsible for ensuring timely completion of AP investigations
  • Responsible for performing process confirmations to ensure compliance & process improvements
  • Other duties, as required

 

Environmental (EM)

  • Responsible for investigation & solution of EM Excursions
  • Deviations Minor & Major
  • Ensure compliance with training programs (ISOtrain/Eduneering)
  • Work directly with shift teams to provide quick containments & in-depth root cause analysis
  • Work directly with QAQC to provide better written deviations & investigations
  • Drive effectiveness of quality processes. Reduce number of major deviations & improve the timeliness of investigations
  • Actively communicate corrective actions from investigations & confirm with all shift teams
  • Ensure compliance with DFP standards
  • Work with Process Technical Analysts & QA to develop simplicity in the deviation process
  • Responsible for developing & performing training on aseptic concepts
  • Responsible for identifying aseptic process needs & improvement opportunities
  • Responsible for performing root cause analysis investigations for environmental excursions through use of SPS tools
  • Responsible for ensuring timely completion of EM investigations
  • Responsible for performing process confirmations to ensure compliance & process improvements
  • Other duties, as required

 

Education

BS/BA in life sciences, engineering, computer science, or related field, or equivalent combination of education & experience.

 

Experience

  • Minimum of five (5) years of manufacturing experience in a pharmaceutical environment. (AP & EM)
  • Minimum of two (2) years of Aseptic Processing Experience. (AP)
  • Environmental Monitoring experience preferred. (EM)

 

Technical/Process/Functional Knowledge

  • Ability to read, write & understand standard operating procedures with attention to high-level concepts
  • Excellent written communication skills, investigative writing & computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP & novoLIMS)
  • Ability to drive continuous improvements via Lean tools & Six Sigma methodologies
  • Knowledge of Aseptic conduct & behaviors in a pharmaceutical environment
  • Knowledge of US, EU regulations & guidelines & application of Good Manufacturing Practices (GMP’s)
  • Demonstrated knowledge of adult learning methodologies & ability to use multiple methods to train & coach others
  • Demonstrated experience in practical problem solving & process improvement methods

 

Organization/Planning

  • Ability to manage multiple tasks/deadlines & prioritize properly based on process needs. Demonstrated effectiveness in systematic follow-up
  • Proven expertise in planning/organizing, managing execution, checking results & revising plans

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 30 pounds within the facility
  • Constantly operates a computer & other office equipment using hands
  • Able to travel internationally, up to 10% of the time
  • 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

 

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

 

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.

Process Area Specialist I - AP

Clayton, NC
Full Time

Published on 10/26/2020