Senior Quality Assurance Area Specialist I - Audits & Inspections

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 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 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.

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 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.

The Position

The primary focus area of this role will be Audits and Inspections.  The Sr. QA Area Specialist will host internal audits, serves as facilitator during and coordinate all activities relating to audit preparation.  Additionally the QA department is responsible for the production activities & validation. Ensures relevant compliance issues are addressed & handled in close collaboration with production. Main duties include review of batch reports & release of incoming materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.

Relationships

Manager, Quality Assurance.

Essential Functions

• Ensures plant systems batch release & relevant quality processes are compliant with regulations
• Has product release authority
• 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
• Provides QA presence & process confirmation on shop floor
• Ability to support all processes & functions in Department
• Quality Risk Management
• 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
• Provides coaching to Site regarding quality & compliance related activities
• Facilitates sharing of regulatory & compliance expectations
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

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

• Bachelor’s degree in life sciences or related field of study from an accredited university required
• With P&O review/agreement, equivalent combination of education & internal NN business/operational experience may be substituted for degree as appropriate
• Minimum of five (5) years of QA &/or related quality experience in manufacturing, utility &/or packaging systems required, preferably in the pharmaceutical or medical device field
• Demonstrated expertise in Regulations & quality systems (e.g., commercial product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, etc.) required
• Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity preferred
• Experience with Risk Assessment & Vendor Assessments required
• Minimum of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation required
• Excellent troubleshooting skills with ability to identify root cause of problem required
• Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing QC, IT & process utilities preferred
• Excellent written & verbal communication skills required
• Auditing experience with certification preferred (internal/external)
• Experience with LEAN, Six Sigma & other continuous improvement methodologies preferred
• Expert competence in one or more core validation areas (packaging, cleaning, utilities, process, or computer validation) required
• Knowledge of statistical methods (hypothesis testing, sampling, trending, etc.) a plus
• Expert in utilizing appropriate root-cause analysis tools & techniques a plus
• Experience with Risk Assessment & Risk Management preferred
• Demonstrated excellence with time management, organizational & project management skills required
• Fosters innovation by challenging ‘tried & tested’ ways of doing things a must
• Eliminates non-value-added practices a must

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.