QA Area Specialist - SDF; 1st shift

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on 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 Emerging Technologies - Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

• 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 14 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.

Ensure Batch Production Records (BPRs) and/or relevant quality processes are compliant with regulations and/or relevant standard operating procedures (SOPs) and guidance. Accountable for Quality review & approval of Change Requests (CRs), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor.

Reports to Manager, Quality Assurance.

• 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 duties as assigned

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 require 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.

• Associate's degree in life sciences or related field from an accredited college required. Bachelor's degree preferred
• May consider a High School Diploma or GED with a minimum of six (6) years of experience in QA or related quality experience
• Minimum of two (2) years QA and /or quality related, or API experience required, preferably in the pharmaceutical industry
• Quality Experience preferred
• General knowledge of pharmaceutical regulations & quality systems preferred
• Knowledge of Quality and one or more of the following:
  Aseptic Production, Business Support, QC, Production Support, Warehousing/Transport, API, and/or Finished Production processes preferred
• Excellent written & verbal communication skills required
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. Required

We commit to an inclusive recruitment process…