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QA Area Specialist II

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.

 

Position Purpose

Ensures Batch Production Records (BPRs) & relevant quality processes are compliant with regulations. Release of raw materials. Quality oversight, review & approval of validation activities associated with minor changes to existing systems. Prepare periodic system evaluations for maintaining validated state. Quality review & approval of Change Requests (CR’s), Deviations & other documentation. Performs Self Audits (in conjunction with LoB), QA presence & process confirmation on shop floor.

 

Accountabilities

  • Ensures site compliance with Regulations, ISO standards, corporate & local Standard Operating Procedures (SOPs)
  • Reviews & approves documentation for Quality approval – components/raw material, batch records, change control requests, deviations & validation documents
  • Participates in project teams as a quality resource
  • Supports, reviews & approves investigations & root-cause analysis
  • Participates in process confirmations & Go Look Sees
  • Evaluates trend & report data for QMRs & APR reports
  • Other duties, as assigned

 

Required Qualifications

BA/BS degree in life sciences or related field, or an equivalent combination of education & experience.

 

Desired Qualifications

  • Minimum of 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, NC/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, Aseptic Production, Business Support, QC, O&P and/or Finished Production 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 & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
  • 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
  • Able to adjust schedule to work with colleagues in other international time zones
  • Some roles require ability to work 12 hour shifts or longer, day or night
  • Able to travel domestically and/or internationally, as necessary

 

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.
 

QA Area Specialist II

Clayton, NC
Full Time

Published on 03/26/2021

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