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Quality Assurance Area Specialist III

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.

 

Position Purpose

Ensures plant systems batch release & relevant quality processes are compliant with regulations. Has product release authority (AQP). Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems & maintaining validated state. Presentation, support & coaching for audits & inspections. Review & approval of complex Change Requests (CR’s), Deviations, CAPAs & other documentation. Performs Self Audits (in conjunction with LoB); Quality Assurance (QA) presence & process confirmation on shop floor. Site Clayton Process Representative, as assigned. Able to support all processes & functions in Department. Quality Risk Management.

 

Accountabilities

  • Makes decisions on quality & compliance issues with little guidance
  • Participates in process group activities as assigned & leads local implementations
  • Ensures site compliance with Regulations, ISOISP standards, corporate & local SOPs
  • Leads improvement activities/improvement of standards within the assigned process
  • Reviews & approves change control documentation, SOPs & other cGMP documentation
  • Provides coaching to Site regarding quality & compliance related activities
  • Supports, reviews & approves complex cross-functional investigations & root-cause analysis
  • Facilitates sharing of regulatory & compliance expectations
  • Reviews & approves complex DVs, CRs, SOPs, trend & report data for CAPA, 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 7 years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in the pharmaceutical or medical device field
  • Demonstrated expertise in Regulations & quality systems (e.g. product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, etc.)
  • Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity
  • Experience with Risk Assessment & Vendor Assessments
  • Expert in cGMP documentation practices.  Requires a minimum of 4 years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation
  • Excellent troubleshooting skills; able to identify root cause of problem
  • Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing QC, IT & process utilities
  • Excellent written & verbal communication skills
  • Auditing experience with certification preferred (internal/external)
  • Experience with LEAN, Six Sigma & other continuous improvement methodologies
  • Expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation)
  • Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.)
  • Expert in utilizing appropriate root-cause analysis tools & techniques
  • Experience with Risk Assessment & Risk Management
  • Demonstrated excellence with time management, organizational & project management skills. Fosters innovation by challenging ‘tried & tested’ ways of doing things. Eliminates non-value-added practices. Expertise in planning/organizing, checking results & revising the work plan for complex problems being resolved by cross functional teams

 

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
  • Able to travel domestically & internationally up to 15% of the time

 

​​​​​​​Novo Nordisk requires all employees to be fully vaccinated with a COVID-19 vaccine by December 8, 2021.  As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. 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.