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Senior Process Technical Analyst

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?

 

Position Purpose:

Departmental leader for technical analysis, process improvements & quality topics. Works with other members of the departmental leadership team to ensure systems are in place to drive process quality & area improvements, complete Quality Systems responses, ensure audit readiness & share ideas & solutions with internal/external departments & sites.

 

Accountabilities

  • Responsible for oversight & coaching for those leading large scale investigations involving departmental discrepancies: Non-conformities, Internal & Customer complaints, Audits, Failure investigations
  • Lead & coach departmental personnel, specialists, leaders, & process technical analysts in problem solving for process & quality issues
  • Performs analysis to provide data to support leadership in developing systems to improve processes & prevent recurrence of problems
  • Evaluate the results of process confirmations of standards for opportunities to leverage & share ideas for improvements Site / division / Company wide.
  • Track & assess effectiveness of corrective / preventative actions from audits/inspections/investigations
  • Understands the processes, understands the products at an advanced level.
  • Closely interacts with all areas to improve the flow of information & products
  • Expert level of knowledge & understanding regarding departmental SOP’s & their high-level inter-relationships (i.e. how they work together to establish a system)
  • Demonstrates expert level of knowledge to enable participation in audits & or inspections & coaching others in successful participation in audits & inspections (both internal & external)
  • Supports Global DFP sites with significant investigations & issues to include on-site support
  • Performs other duties as required.

 

Required Education: 

BS/BA in technical field or industry equivalent experience.

 

Required Experience:

5-10 years of manufacturing experience in a pharmaceutical or related (regulated) environment. (Leadership/Supervisory experience preferred.)

3 - 5 years of Process Technical Analyst (or equivalent) experience.

 

Desired Experience:

5 years of Pharmaceutical manufacturing experience with an appropriate technical process focus (e.g.  Aseptic Processing experience).

 

Technical/Process/Functional Knowledge: 

  • 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.      
  • Demonstrates knowledge of adult learning methodologies & is able to use multiple methods to train & coach others within the department & organization.
  • Excellent verbal & written communication skills, investigative writing skills, & computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP & novoLIMS)
  • Demonstrated experience in practical problem solving & process improvement methods.

 

Organization/Planning:

Demonstrated ability to manage multiple tasks/deadlines & prioritize properly based on process needs & events.  Demonstrated effectiveness in systematic follow-up.

 

Physical and other requirements:                     

  • Ability to attain clean room gowning certification & work with hazardous materials including sanitants.
  • Ability to work hours necessary to support shift production.
  • Ability to travel internationally.
  • Must be able to achieve core gown certification.

 

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.

Senior Process Technical Analyst

Clayton, NC
Full Time

Published on 06/16/2020