Quality Assurance Area Specialist II

About the Department

At Novo Nordisk, we want to make a difference. For more than 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 NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

 

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

 

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.
 

 

The Position

Ensure Batch Production Records (BPRs) & relevant quality processes are compliant with regulations and associated corporate and local standard operating procedures (SOPs)Release of raw materials. Quality oversight, review & approval of validation activities associated with minor changes to existing systems. Review periodic system evaluations for maintaining validated state. Quality review & approval of Change Requests (CR's), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor with stakeholder.

 

Relationships

Senior Manager, Quality Assurance.

 

Essential Functions

• Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs
• Review & approve documentation for Quality approval – components/raw material, batch records, change control requests, deviations, , Quality Control (QC)  laboratory investigations, SOPs & validation documents
• Participate in project teams as a quality resource
• Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement techniques
• Participate in process confirmations & Go Look Sees
• Evaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review (APR) reports
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

 

Physical Requirements

May move equipment &/or supplies weighing up to thirty-three (33) pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.

 

Qualifications

• High School Diploma (GED) required
• Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred
• Minimum of four (4) years of QA and/or quality related experience in the pharmaceutical or medical device industry with progressively increasing responsibility required
• General knowledge of regulations & quality systems (e.g., product disposition, deviations, Change Control, Audits, Supplier Management, Project Management, etc.) preferred
• Familiarity with local processes & quality systems preferred
• Familiarity with risk assessment/risk management preferred
• Demonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferred
• Knowledge of Quality, and /or Aseptic Production, Business Support, QC, IT, Facilities/Utilities, warehousing/logistics, O&P, and Finished Production processes preferred
• Knowledge of US, EU regulations & guidelines, ISO standards & application of Good Manufacturing Practices (GMPs) preferred
• Excellent written & verbal communication skills required