Quality Assurance Area Specialist III - Finished Production

Quality Assurance Area Specialist III - Finished Production

Facility:
Quality

Location:

Clayton, NC, US

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 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

This position will perform general QA compliance activities for our Finished Production unit. This 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. This is an onsite based role Monday-Friday.

Relationships

Reports to:

Associate Director, QA Finished Production

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

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 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…