Life Sciences QA Job at Novo Nordisk – Apply Now!
Are you an experienced quality professional looking to take your career to the next level in a world-class pharmaceutical manufacturing environment? Novo Nordisk is seeking a Quality Assurance Area Specialist III for its Clayton, North Carolina site. This is your opportunity to join a global healthcare leader and make a direct impact on the quality and compliance of life-saving diabetes and obesity treatments. If you’re passionate about continuous improvement, regulatory excellence, and helping people live healthier lives, this role is for you.
About Novo Nordisk
For over a century, Novo Nordisk has been a global pioneer in diabetes care, committed to improving the quality of life for millions of people around the world. Headquartered in Denmark and operating in over 80 countries, Novo Nordisk is known not only for its groundbreaking treatments but also for fostering a culture of innovation, integrity, and care. At our Clayton, North Carolina campus, we operate three state-of-the-art pharmaceutical manufacturing facilities, including the Product Supply Aseptic Manufacturing (PS AM) site. This 457,000 sq. ft. facility is dedicated to the aseptic “fill and finish” of injectable products — playing a critical role in our mission to deliver high-quality medicines to patients everywhere. Joining Novo Nordisk means becoming part of a purpose-driven organization with exceptional benefits, growth opportunities, and a focus on work-life balance. Be a part of something bigger — make what matters.
Job Details:
Job Role: Quality Assurance Area Specialist III
Facility: Quality
Location: Clayton, NC, US
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 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
Ensures plant systems batch release, and/or relevant quality processes are compliant with regulations. Has product release authority if role is in batch release. Quality oversight, review & approval of validation activities and documents associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems. Presentation, support & coaching for audits & inspections. Review & approval of complex Change Requests (CR’s), Deviations (DVs), CAPAs & other documentation. Performs Self Audits (in conjunction with line of business (LoB)); Quality Assurance (QA) presence & process confirmation on shop floor. Site Clayton Process Representative, as assigned. Able to support all processes & functions in Department. Trends and reports data as applicable.
Relationships: Senior Manager, Quality Assurance.
Essential Functions
- Make decisions on quality & compliance issues with little guidance
- Participate in process group activities as assigned & leads local implementations
- Ensure site compliance with Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs)
- Lead improvement activities/improvement of standards within the assigned process
- Review & approves change control documentation, SOPs & other current good manufacturing practice (cGMP) documentation
- Provide 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, Quality Management Reviews (QMRs) & Annual Product Review (APR) reports
- Eliminates non-value-added practices
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned
Physical Requirements
Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. 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. ***If hired as a AQP, Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university required
- Minimum of seven (7) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in the pharmaceutical or medical device field required
- Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred
- Quality Risk Management experience required
- Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity required
- Experience in use of Risk Assessment & Vendor Assessments during evaluation of change controls, deviation and validation activities required
- Expert in cGMP documentation practices. Requires a minimum of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation preferred
- Excellent troubleshooting skills; able 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) required
- Experience with LEAN, Six Sigma & other continuous improvement methodologies required
- Expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation) preferred
- Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required
- Expert in utilizing appropriate root-cause analysis tools & techniques preferred
- Experience with Risk Assessment & Risk Management required
- Demonstrated excellence with time management, organizational & project management skills required
Keywords: Novo Nordisk, Quality Assurance, Specialist, Clayton, NC, Quality control, Compliance, Pharmaceutical manufacturing
