Quality Assurance Area Specialist I

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 Product Supply Aseptic Manufacturing (PS AM) 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 PS AM, 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) and/or relevant quality processes are compliant with regulations and/or relevant standard operating procedures (SOP's) and guidance. Accountable for 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. Relationships Senior Manager. Essential Functions Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs Review & approve documentation for Quality approval – batch records and other documentation Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement Participate in process confirmations & Go Look Sees Evaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review (APR) reports Perform QA role to review and approve local production related Customer Complaint Investigations (escalate if necessary) Participate in & support the audit management team as needed during internal, external audits and inspections Responsible for training of AP and FP members responsible for conducting investigations Follow all safety & environmental requirements in the performance of duties Other accountabilities, as assigned Physical Requirements 0-10% overnight travel required. May move equipment &/or supplies weighing up to 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 or equivalent (GED) required Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred Minimum of two (2) years of pharmaceutical or medical device experience with progressively increasing responsibility required Quality Experience preferred General knowledge of pharmaceutical regulations & quality systems preferred Familiarity with local processes & quality systems preferred Knowledge of Quality and one or more of the following: Aseptic Production, Business Support, QC, Production Support, Warehousing/Transport, and/or Finished Production processes preferred Knowledge of Good Manufacturing Practices (GMPs) in related area required Excellent written & verbal communication skills required Basic computer skills in MS Office, MS Project, PowerPoint, etc. required 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 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.