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QA Area Specialist OFP

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. We are currently seeking top talent for our new OFP tableting facility located in Durham, NC.

 

 

Position Purpose

Responsible for review and/or approval of Deviations, Change Requests/SOPs, Training Material, Laboratory Investigations & Trend Reports; Supplier Program management; self-audits (in conjunction with LoB); QA presence & process confirmation on shop floor & improvement of quality processes.

 

 

Accountabilities

  • Ensure site compliance with Regulations, ISO standards & corporate/local SOPs
  • Review & approve change control requests
  • Participate in project teams as the compliance resource
  • Provide guidance to departments regarding quality-related activities
  • Support, review & approve cross-functional investigations & root-cause analysis
  • Participate in process confirmations & Go-Look-Sees
  • Participate in knowledge & experience sharing with other QA team members to assure compliance with company procedures, policies & objectives
  • Evaluate trend & report data for QMRs & APR reports
  • Perform other duties as assigned

Required Qualifications
BA/BS degree (preferably in Life Sciences, Engineering, or related field).

Desired Qualifications

  • Minimum of four (4) years of QA and/or quality-related experience in the pharmaceutical or medical device industry, with progressively increasing responsibility
  • General knowledge of regulations & quality systems (e.g. product disposition, Deviations/CAPA, Change Control, Audits, Supplier Management, Project Management, etc.)
  • Familiarity with local processes & quality systems
  • Demonstrated knowledge of critical controls & input/output requirements for NNPILP processes
  • Knowledge of Quality, Production, Business Support and/or QC processes
  • Knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in aseptic manufacturing
  • Excellent written & verbal communication skills
  • Basic computer skills in MS Office, MS Project, PowerPoint, etc.
  • Auditing experience with certification preferred
  • Experience in the use of Six Sigma & LEAN tools
  • Personal Time Management: Sets goals & prioritizes tasks for own work on short-term basis, meets deadlines & makes regular progress reports on performance. Keeps track & informs management about fluctuation in workload. Performs well with multi-tasking. Adjust priorities in accordance with changing circumstances. Keeps all relevant people informed of current & future plans

Physical Requirements

  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
  • Constantly operates a computer & other office equipment using hands
  • Normal office environment
  • Must be willing to flex work hours according to the demands of a 24/7 operation
  • Able to travel internationally on a limited basis

 

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.

QA Area Specialist OFP

Durham, NC
Full Time

Published on 04/06/2020